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Silicone Sheeting

FDA UDI

Class I (US FDA UDI)

by Summit Medical, LLC

Identity

Trade Name
SILICONE SHEETING FDA UDI
Generic Name
Silicone-sheet tissue reconstructive material FDA UDI
Model / Reference
SP-66100 FDA UDI

Identifiers

Primary DI / UDI-DI
00385640033350 FDA UDI
FDA Product Code
MDA FDA UDI
GMDN Term
Silicone-sheet tissue reconstructive material FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4025 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Silicone-sheet tissue reconstructive material

SILICONE SHEETING is a cutting-edge, implantable tissue reconstructive material designed for various surgical procedures. This silicone sheet is modified to suit individual patient anatomy and can be tailored for specific applications such as nasal septum repair or orbital floor reconstruction.

Similar devices

Also classified as Silicone-sheet tissue reconstructive material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Summit Medical, LLC

Sources (1)

  • FDA UDI b85bbc45-679d-4f0c-a8f3-f665d60f4c46 32 fields · synced Jul 23, 2026