FDA UDI In Commercial Distribution 🇺🇸 United States

Archimed 627 Spinal Brace

DI: 00802357633258 · Model: 163325 · MEDICAL SPECIALTIES INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Archimed 627 Spinal Brace
Primary DI
00802357633258
Version / Model
163325
Company Name
MEDICAL SPECIALTIES INCORPORATED
Labeler DUNS
003173028
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-07
Public Version
1
Public Version Date
2022-12-15
Public Version Status
New
Public Device Record Key
c8f9f5ca-95c2-4c68-a0bd-70a34680e396

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IPY Orthosis, Lumbo-Sacral

GMDN Terms

Code Name
33031 Lumbar spine orthosis

Identifiers

Type ID
Primary 00802357633258