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Technical Products

FDA UDI

Class II (US FDA UDI)

by Technical Products, Inc.

Identity

Trade Name
Technical Products FDA UDI
Generic Name
Silicone-sheet tissue reconstructive material FDA UDI
Device Name
silicone sheet sterile FDA UDI
Model / Reference
500-9S68 FDA UDI
Description
silicone sheet sterile FDA UDI

Identifiers

Primary DI / UDI-DI
B0515009S680 FDA UDI
510(k) Number
K971472 FDA UDI
FDA Product Code
FTL FDA UDI
GMDN Term
Silicone-sheet tissue reconstructive material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Silicone-sheet tissue reconstructive material

Technical Products by Technical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Silicone-sheet tissue reconstructive material.

Cleared under the same submission

K971472 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Technical Products, Inc.

Sources (1)

  • FDA UDI 78a4e9f9-34bc-40b8-bcd0-b76789fdb430 35 fields · synced May 30, 2026