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Unisilk

FDA UDI

Class II (US FDA UDI)

by United Medical Industries Co. Ltd

Identity

Trade Name
UNISILK FDA UDI
Generic Name
Silk suture FDA UDI
Device Name
Braided Silk, Natural Non-Absorbable Surgical Sututres / Ligatures FDA UDI
Model / Reference
DW2943 FDA UDI
Description
Braided Silk, Natural Non-Absorbable Surgical Sututres / Ligatures FDA UDI

Identifiers

Catalog Number
DW2943 FDA UDI
Primary DI / UDI-DI
16285379148879 FDA UDI
510(k) Number
K042282 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

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.3 Millimeter FDA UDI

Category: Silk suture

Unisilk by United Medical Industries Co. Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Silk suture.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 34c461e9-00e4-481f-87ea-b01ec5b646e6 38 fields · synced May 30, 2026