← Back to catalogue

Exmoor

FDA UDI

Class II (US FDA UDI)

by Exmoor Plastics , Ltd.

Identity

Trade Name
EXMOOR FDA UDI
Generic Name
Silicone-sheet tissue reconstructive material, non-sterile FDA UDI
Device Name
Silicone rubber sheet FDA UDI
Model / Reference
SRS.6a(29) FDA UDI
Description
Silicone rubber sheet FDA UDI

Identifiers

Catalog Number
SRS6A(29) FDA UDI
Primary DI / UDI-DI
05060180252106 FDA UDI
510(k) Number
K911503 FDA UDI
FDA Product Code
KHJ FDA UDI
GMDN Term
Silicone-sheet tissue reconstructive material, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3620 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

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Silicone-sheet tissue reconstructive material, non-sterile

Exmoor by Exmoor Plastics , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Silicone-sheet tissue reconstructive material, non-sterile.

Cleared under the same submission

K911503 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Exmoor Plastics , Ltd.

Sources (1)

  • FDA UDI 5620bcda-a2f1-49a7-84ba-75581813363a 37 fields · synced Jun 1, 2026