FDA UDI In Commercial Distribution 🇺🇸 United States

XcelGel

DI: 00810048240210 · Model: PC1004 · POLYMER CONCEPTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
XcelGel
Primary DI
00810048240210
Version / Model
PC1004
Company Name
POLYMER CONCEPTS, INC.
Labeler DUNS
010560097
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-04-27
Public Version
2
Public Version Date
2020-11-19
Public Version Status
Update
Public Device Record Key
95f8d7f3-afed-4e5d-ae9c-256c4bcb79f8

Device Description

PC1004 Foot Section Hip Pad 20" x 20" x 1/2"

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LWG Surgical Table Cushion

GMDN Terms

Code Name
31684 Operating table patient pressure distribution pad, reusable

Identifiers

Type ID
Primary 00810048240210

Customer Contacts

Phone
4409539605