FDA UDI In Commercial Distribution 🇺🇸 United States

XcelGel

DI: 00810048240845 · Model: PC1053 · POLYMER CONCEPTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
XcelGel
Primary DI
00810048240845
Version / Model
PC1053
Company Name
POLYMER CONCEPTS, INC.
Labeler DUNS
010560097
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-26
Public Version
2
Public Version Date
2020-11-19
Public Version Status
Update
Public Device Record Key
cdd316fb-5a57-4888-838b-4e8da05183b5

Device Description

PC1053 Bariatric Knee Cruth Pad Medium 17" x 11" x 1"

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 00810048240845

Customer Contacts

Phone
4409539605