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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
PC1212 Summersvile Pad 12" x 12" x 1/4" FDA UDI
Model / Reference
PC1212 FDA UDI
Description
PC1212 Summersvile Pad 12" x 12" x 1/4" FDA UDI

Identifiers

Primary DI / UDI-DI
00810048241897 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

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Manufacturer

Manufacturer
Polymer Concepts, Inc.

Sources (1)

  • FDA UDI c00ea40b-c68e-4959-b4c7-94dd20f2d9ac 34 fields · synced Jun 8, 2026