← Back to catalogue

XcelGel

FDA UDI

Class I (US FDA UDI)

by Polymer Concepts, Inc.

Identity

Trade Name
XcelGel FDA UDI
Generic Name
Operating table patient pressure distribution pad, reusable FDA UDI
Device Name
PC1090 Lap Band Belt 60" x 4" x 1/4" FDA UDI
Model / Reference
PC1090 FDA UDI
Description
PC1090 Lap Band Belt 60" x 4" x 1/4" FDA UDI

Identifiers

Primary DI / UDI-DI
00810048241200 FDA UDI
FDA Product Code
LWG FDA UDI
GMDN Term
Operating table patient pressure distribution pad, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 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

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Operating table patient pressure distribution pad, reusable

XcelGel by Polymer Concepts, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table patient pressure distribution pad, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Polymer Concepts, Inc.

Sources (1)

  • FDA UDI ff9c6fe1-2761-4b46-be7f-94dae6ce9b50 34 fields · synced May 30, 2026