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Prosthetic Silicone Materials

FDA UDI

Class I (US FDA UDI)

by Technovent Limited

Identity

Trade Name
Prosthetic Silicone Materials FDA UDI
Generic Name
External limb prosthesis finishing component, custom-made FDA UDI
Device Name
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials FDA UDI
Model / Reference
AlSil Gum 35 Shore – 1kg FDA UDI
Description
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials FDA UDI

Identifiers

Catalog Number
AL35A FDA UDI
Primary DI / UDI-DI
05060483013053 FDA UDI
FDA Product Code
GBI FDA UDI
GMDN Term
External limb prosthesis finishing component, custom-made FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.3800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: External limb prosthesis finishing component, custom-made

Prosthetic Silicone Materials by Technovent Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External limb prosthesis finishing component, custom-made.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Technovent Limited

Sources (1)

  • FDA UDI a2c29fe7-1bf3-40f9-b4b2-7ebaa0bbe588 35 fields · synced May 31, 2026