Golnit Nylon Monofilament Suture

FDA UDI

Class II (US FDA UDI)

by Golnit Sutures

Identity

Trade Name: Golnit Nylon Monofilament Suture FDA UDI
Generic Name: Polyolefin/fluoropolymer suture, monofilament FDA UDI
Device Name: Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 3/0, Reverse Cutting Needle, 19mm, 3/8 curvature, Sterile FDA UDI
Model / Reference: NB2D3019-75 FDA UDI
Description: Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 3/0, Reverse Cutting Needle, 19mm, 3/8 curvature, Sterile FDA UDI

Identifiers

Primary DI / UDI-DI: 00850043243038 FDA UDI
FDA Product Code: GAR FDA UDI
GMDN Term: Polyolefin/fluoropolymer suture, monofilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 30 Inch FDA UDI

Category: Polyolefin/fluoropolymer suture, monofilament

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

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Also classified as Polyolefin/fluoropolymer suture, monofilament.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Golnit Sutures

Sources (1)

FDA UDI e4f6ea00-7cae-4804-bdcc-b117bf7d140a 34 fields · synced May 29, 2026