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Golnit PTFE Suture

FDA UDI

Class II (US FDA UDI)

by Golnit Sutures

Identity

Trade Name
Golnit PTFE Suture FDA UDI
Generic Name
Polytetrafluoroethylene suture FDA UDI
Device Name
PTFE Non-absorbable Suture 18 Inch in length, USP 5/0, Reverse Cutting Needle, 13mm, 3/8 curvature, Sterile FDA UDI
Model / Reference
mRD501343-45 FDA UDI
Description
PTFE Non-absorbable Suture 18 Inch in length, USP 5/0, Reverse Cutting Needle, 13mm, 3/8 curvature, Sterile FDA UDI

Identifiers

Primary DI / UDI-DI
00860293000619 FDA UDI
FDA Product Code
NBY FDA UDI
GMDN Term
Polytetrafluoroethylene suture FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5035 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 18 Inch FDA UDI

Category: Polytetrafluoroethylene suture

Golnit PTFE Suture by Golnit Sutures — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polytetrafluoroethylene suture.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Golnit Sutures

Sources (1)

  • FDA UDI 774da996-5d02-4185-81ae-f6c69c6e8beb 34 fields · synced May 29, 2026