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510(k) Data Aggregation
K Number
K994001Device Name
POLYGLYCOLIC ACID
Manufacturer
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
Date Cleared
2000-02-09
(77 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
POLYGLYCOLIC ACID is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Device Description
POLYGLYCOLIC ACID is a synthetic absorbable sterile surgical suture composed of a synthetic polyglycolic acid polymer and is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. POLYGLYCOLIC ACID meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. Offered as monofilament or multifilament in form, and it is offered uncoated or coated with polycarpolactone and calcium stearate, it could also be undyed or dyed with an FDA listed color additive, D&C Violet No. 2 (21CFR74.3602). POLYGLYCOLIC ACID will be offered with or without standard needles attached.
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K Number
K993997Device Name
POLYPROPYLENE
Manufacturer
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
Date Cleared
2000-02-04
(72 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
POLYPROPYLENE is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
POLYPROPYLENE is a nonabsorbable sterile surgical monofilament suture composed of flexible thread prepared from Long-chain polyolefin polymer known as polypropylene and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYPROPYLENE meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered undyed or dyed with an FDA listed color additive, either D&C Blue No. 6, (21CFR74.3106) or D&C Blue No. 6 (21CFR74.3106) or [Phthalocyaninato(2-)] copper (21CFR74.3045). It will be offered with or without standard needles attached.
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K Number
K993998Device Name
NYLON
Manufacturer
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
Date Cleared
2000-02-04
(72 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NYLON is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
NYLON is a nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6 and/or Nylon 6,6. NYLON meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered coated or uncoated, undyed and dyed with an appropriate FDA listed color additive, D&C Blue No. 2. (21CFR74.3102) or Logwood extract, C.I. Natural Black 1. (21CFR74.1410). NYLON will be offered with or without standard needles attached.
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K Number
K993999Device Name
SILK
Manufacturer
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
Date Cleared
2000-02-04
(72 days)
Product Code
GAP
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SILK is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
SILK is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.
SILK is offered braided, uncoated or silicon coated, undyed or dyed with an FDA listed color additive, D&C Blue No. 9 (21CFR74.1109), or Logwood extract, C.I. Natural Black 1 (21CFR74.1410). SILK meets the United States Pharmacopeia (U.S.P.) monograph requirements for nonabsorbable silk surgical sutures.
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K Number
K994000Device Name
POLYESTER
Manufacturer
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
Date Cleared
2000-02-04
(72 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
POLYESTER is a nonabsorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high-molecular weight, longchain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYESTER meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form. POLYESTER could be offered coated or uncoated, undyed or dyed with an FDA listed color additive, D&C Green No. 6. (21CFR74.3206). POLYESTER will be offered with or without standard needles attached.
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K Number
K994002Device Name
PLAIN/CHROMIC CATGUT
Manufacturer
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
Date Cleared
2000-02-04
(72 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Applicant Name (Manufacturer) :
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CATGUT is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Device Description
CATGUT, Plain and Chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. CATGUT meets the United States Pharmacopeia (U.S.P.) standards for Absorbable Surgical Sutures. It will be offered uncoated or coated with glycerol and with or without standard needles attached.
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