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510(k) Data Aggregation
K Number
K180630Device Name
PTFE SURGICAL SUTURE
Manufacturer
OMNIA SPA
Date Cleared
2018-04-06
(28 days)
Product Code
NBY
Regulation Number
878.5035Why did this record match?
Applicant Name (Manufacturer) :
OMNIA SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PTFE SURGICAL SUTURE is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in cardiovascular surgery, ophthalmic surgery, and neural tissue.
Device Description
PTFE SURGICAL SUTURE
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K Number
K132464Device Name
PTFE SURGICAL SUTURE
Manufacturer
OMNIA SPA
Date Cleared
2014-02-12
(189 days)
Product Code
NBY
Regulation Number
878.5035Why did this record match?
Applicant Name (Manufacturer) :
OMNIA SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PTFE Surgical Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgenes. The device is not in cardiovascular surgery, ophthalmic surgery, microsurgery, and neural tissue.
Device Description
PTFE Surgical Suture
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K Number
K110724Device Name
SURGICAL PROCEDURE PACKS
Manufacturer
OMNIA SPA
Date Cleared
2011-06-23
(99 days)
Product Code
FYA, FXX, KKX, LRO
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
OMNIA SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical Procedure Packs are kits for oral implantology, used by dental professionals when performing surgical procedures.
Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries.
Device Description
Omnia Surgical Procedure Packs are composed of disposable devices, drapes, and surgical garb intended for professional use in preparing the operating environment with protective coverings that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries. The contents of these kits may include:
- Surgical Gowns (various models) with or without hand towels ●
- Sterile Surgical Drapes (various models) .
- Face mask .
- Protective caps .
- Sheath/Tubing Sleeve .
- Surgical aspirator with adaptor .
- Surgical Gauze .
- Sterile disinfection sponge and/or basin .
- Adhesive Film .
- Syringe (s) .
- Needle(s) .
- . Single-use scalpel
- Small dental mirror/dental explorer/tweezer .
- Bone collector ●
- . Saliva ejector
- . Irrigation/Infusion line
- Stopcock and ramp for infusion .
- Waste bag for contaminated material .
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