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Silicone Sheeting Open Border

FDA UDI

Class II (US FDA UDI)

by Bentec Medical OpCo, LLC.

Identity

Trade Name
Silicone Sheeting Open Border FDA UDI
Generic Name
Silicone-sheet tissue reconstructive material FDA UDI
Model / Reference
PR72034-02 FDA UDI

Identifiers

Primary DI / UDI-DI
00684995320024 FDA UDI
510(k) Number
K840172 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Silicone-sheet tissue reconstructive material

Silicone Sheeting Open Border by Bentec Medical OpCo, LLC. — 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

K840172 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bentec Medical OpCo, LLC.

Sources (1)

  • FDA UDI 86836fab-8ee3-445f-855a-82380a41adcc 33 fields · synced May 31, 2026