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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, non-sterile FDA UDI
Device Name
silicone sheet radiopaque FDA UDI
Model / Reference
400-60 4x8 FDA UDI
Description
silicone sheet radiopaque FDA UDI

Identifiers

Primary DI / UDI-DI
B051400604X80 FDA UDI
510(k) Number
K971472 FDA UDI
FDA Product Code
FTL FDA UDI
GMDN Term
Silicone-sheet tissue reconstructive material, non-sterile 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

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

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, non-sterile.

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 5e91760a-33aa-467a-a391-eb084da0d921 35 fields · synced May 31, 2026