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Silk

FDA UDI

Class II (US FDA UDI)

by Resorba Medical GmbH

Identity

Trade Name
SILK FDA UDI
Generic Name
Silk suture FDA UDI
Model / Reference
SILK FDA UDI

Identifiers

Primary DI / UDI-DI
E203US40228 FDA UDI
510(k) Number
K143582 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Silk suture

Silk by Resorba Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Silk suture.

Cleared under the same submission

K143582 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Resorba Medical GmbH

Sources (1)

  • FDA UDI be15f409-f9e8-4f17-931a-bc727a63fcdd 33 fields · synced May 31, 2026