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AlliedSil™ Sheeting

FDA UDI

Class II (US FDA UDI)

by Implantech Associates, Inc.

Identity

Trade Name
AlliedSil™ Sheeting FDA UDI
Generic Name
Silicone-sheet tissue reconstructive material, non-sterile FDA UDI
Device Name
Silicone Sheeting Non-Reinforced FDA UDI
Model / Reference
Size: 203.2mm x 152.4mm x 0.381mm FDA UDI
Description
Silicone Sheeting Non-Reinforced FDA UDI

Identifiers

Catalog Number
600-15-NS FDA UDI
Primary DI / UDI-DI
M72460015NS1 FDA UDI
510(k) Number
K971480 FDA UDI
FDA Product Code
MIB 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

AlliedSil™ Sheeting by Implantech Associates, Inc. — 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

K971480 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Implantech Associates, Inc.

Sources (1)

  • FDA UDI 5422fdd5-0273-4b60-8704-d395264cfa4f 36 fields · synced Jun 9, 2026