FDA UDI In Commercial Distribution 🇺🇸 United States

Span-America

DI: H93380161805 · Model: Gel-T · SPAN-AMERICA MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Span-America
Primary DI
H93380161805
Version / Model
Gel-T
Catalog Number
80161805
Company Name
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Labeler DUNS
073704413
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-02
Public Version
1
Public Version Date
2022-12-12
Public Version Status
New
Public Device Record Key
4d665193-f67f-4075-9bc4-c643a267148c

Device Description

GEL-T 16X18 PU ULTRA/BVINYL

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
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KIC Cushion, Flotation

GMDN Terms

Code Name
63237 Foam bed mattress

Identifiers

Type ID
Primary H93380161805