Sutrasilk

FDA UDI

Class II (US FDA UDI)

by Visionary Medical Supplies, Inc.

Identity

Trade Name: Sutrasilk FDA UDI
Generic Name: Silk suture FDA UDI
Device Name: 7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specifications: ST-140-9, Spatula Tip, 3/8 circle (140 degrees), length 6.6 mm, wire 0.23mm / # of needles: Double arm FDA UDI
Model / Reference: S74092 FDA UDI
Description: 7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specifications: ST-140-9, Spatula Tip, 3/8 circle (140 degrees), length 6.6 mm, wire 0.23mm / # of needles: Double arm FDA UDI

Identifiers

Primary DI / UDI-DI: M583S740921 FDA UDI
510(k) Number: K994177 FDA UDI
FDA Product Code: GAP FDA UDI
GMDN Term: Silk suture FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5030 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Angle — 140 degree FDA UDI
Length — 45 Centimeter FDA UDI
Length — 6.6 Millimeter FDA UDI
Outer Diameter — 0.23 Millimeter FDA UDI

Category: Silk suture

Sutrasilk by Visionary Medical Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Silk suture.

Sofsilk — Covidien LP · Class II
PERMA-HAND — Ethicon Inc. · Class II
DemeSILK — DemeTECH Corp · Class II
DemeSILK — DemeTECH Corp · Class II
DemeSILK — DemeTECH Corp · Class II
Sofsilk — Covidien LP · Class II
DemeSILK — DemeTECH Corp · Class II
DemeSILK — DemeTECH Corp · Class II

Cleared under the same submission

K994177 also covers:

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: Visionary Medical Supplies, Inc.

Sources (1)

FDA UDI 4724047a-bff6-49ba-9e40-a62804783f18 36 fields · synced Jun 9, 2026