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Found 7 results
510(k) Data Aggregation
K Number
K981441Device Name
HEART CATH TRAY, STERILE, DISPOSABLE
Manufacturer
TRINITY LABORATORIES, INC.
Date Cleared
1998-07-10
(80 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
TRINITY LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Trinity's Heart Cath Tray is a sterile prepackaged disposable unit. It contains the non-reinforced gowns, femoral angio drape, OR cloth towels, absorbent towels, 16 oz sponge bowl, 32 oz sponge bowls, bowl guidewire with lid, 2 oz medicine cups, gauze sponges, straight mosquito forceps, 25 ga x 5/8" needle, 22 ga x 1 1/2" needle, 5cc L/L syringe, 10cc L/L syringe, 20cc L/L syringe, 10cc L/S syringes, towel clips, #11 blade scalpel, table cover, and band bag, neccessary for the performance of the Heart Cath surgical procedure..
Device Description
Trinity's Heart Cath Tray is a sterile prepackaged disposable unit. It contains the non-reinforced gowns, femoral angio drape, OR cloth towels, absorbent towels, 16 oz sponge bowl, 32 oz sponge bowls, bowl guidewire with lid, 2 oz medicine cups, gauze sponges, straight mosquito forceps, 25 ga x 5/8" needle, 22 ga x 1 1/2" needle, 5cc L/L syringe, 10cc L/L syringe, 20cc L/L syringe, 10cc L/S syringes, towel clips, #11 blade scalpel, table cover, and band bag, neccessary for the performance of the Heart Cath surgical procedure..
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K Number
K974238Device Name
DENTAL TRAY, STERILE, DISPOSABLE
Manufacturer
TRINITY LABORATORIES, INC.
Date Cleared
1998-02-04
(84 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
TRINITY LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Trinity's Dental Tray is a sterile prepackaged disposable unit. It contains the gowns, table cover, mayo stand cover, OR towels, bowl, medicine cup, sponges, scalpels, tongue depressor, foam tray, Yankauer, suction tubing, and towels necessary for the performance of basic dental procedures, including but not limited to general cleaning, cavity filling, root canal, and tooth removal.
Device Description
Trinity's Dental Tray is a sterile prepackaged disposable unit. It contains the gowns, table cover, mayo stand cover, OR towels, bowl, medicine cup, sponges, scalpels, tongue depressor, foam tray, Yankauer, suction tubing, and towels necessary for the performance of basic dental procedures, including but not limited to general cleaning, cavity filling, root canal, and tooth removal.
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K Number
K974286Device Name
CIRCUMCISION TRAY, CAT. NO. 70340
Manufacturer
TRINITY LABORATORIES, INC.
Date Cleared
1997-12-12
(28 days)
Product Code
HFX
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
TRINITY LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Trinity's Circumcision Tray is a sterile prepackaged disposable unit. It contains the gauze sponges, straight mosquito forceps, curved mosquito forceps, adson tissue forceps, probe wtih eye, PVP swabsticks, OR scissors, multi-compartment pouch, #10 blade scalpel, and fenestrated cloth OR towel necessary for the performance of the circumcision surgical procedure..
Device Description
Circumcision Tray is a sterile prepackaged disposable unit. It contains the gauze sponges, straight mosquito forceps, curved mosquito forceps, adson tissue forceps, probe wtih eye, PVP swabsticks, OR scissors, multi-compartment pouch, #10 blade scalpel, and fenestrated cloth OR towel.
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K Number
K972160Device Name
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
Manufacturer
TRINITY LABORATORIES, INC.
Date Cleared
1997-08-01
(53 days)
Product Code
DCK
Regulation Number
866.5270Why did this record match?
Applicant Name (Manufacturer) :
TRINITY LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CRP-LEX-SYSTEM is intended to be used, in hospital and other The appropriate clinical laboratories, to detect CRP levels in patient serum specimens around the 8ug/ml (0.8mg/d1) concentration.
The CRP-LEX method is by latex slide agglutination. At CRP levels at or above this noted concentration, agglutination of the CRP-LEX, latex particles should be observed. A screening (qualitative) and semi-quantitative procedure (dilution of the patient specimen) has been included and described.
Device Description
CRP-LEX™ SYSTEM A Latex To Detect C-Reactive Protein In Serum. The CRP-LEX method is by latex slide agglutination.
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K Number
K970722Device Name
EYE TRAY
Manufacturer
TRINITY LABORATORIES, INC.
Date Cleared
1997-03-31
(32 days)
Product Code
KKX, HNM, HNN, HOY
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
TRINITY LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K965201Device Name
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
Manufacturer
TRINITY LABORATORIES, INC.
Date Cleared
1997-02-14
(50 days)
Product Code
LRO
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
TRINITY LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964921Device Name
BASIC BIOPSY TRAY. DISPOSABLE, STERILE
Manufacturer
TRINITY LABORATORIES, INC.
Date Cleared
1997-01-22
(44 days)
Product Code
LRO
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
TRINITY LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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