Golnit PTFE Sutures

PTFE Non-absorbable Suture 18 inch in length, USP 4/0, Reverse Cutting Needle, 16mm, 3/8 curvature, Sterile

Registry build 21.09.26
1manufacturer
3catalogue numbers in this listing

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code NBY
Manufacturer City Province Registered as Device types
Foosin Medical Supplies Inc.ltd Weihai Shandong Manufacturer 8

Record

Regulatory record for Golnit PTFE Sutures
Listed by Golnit Sutures
FDA product code NBY
Device type Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device class Class 2
Regulation 21 CFR 878.5035
Premarket notification Exempt
Record published 2018-03-08
Record revised 2018-10-10 (version 2)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Sizes Length 18 in

Catalogue Numbers

Catalogue numbers for Golnit PTFE Sutures
Catalogue number Size Per pack Status
mRD401648-45 USP 4/0 Suture Thread 12 In distribution
mRD301956-45 Length 18 in 12 In distribution
mRD401853-45 Length 18 in 12 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Demetech PTFE Demetech Corp. 201
Biotex Purgo Biologics Inc. 60
Sterile PTFE Surgical Suture Omnia Medical 45
Monotex Riverpoint Medical LLC 36
Cytoplast™ PTFE Suture Osteogenics Biomedical, Inc. 34
Darby Dental Supply, LLC Darby Dental Supply, LLC 24
Cytosurg Riverpoint Medical LLC 18
Unify PTFE Surgical Sutures Applied Dental, Inc. 13
Klosure Riverpoint Medical LLC 10
Gibson Benco Dental Supply Co. 9
Maxima Henry Schein, Inc. 9
Ptfe Riverpoint Medical LLC 9

Showing 12 of 34. All products under Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

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2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer