FDA UDI In Commercial Distribution 🇺🇸 United States

DARCO® Medical-surgical shoe

DI: 00609271790117 · Model: MQM1B · DARCO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
DARCO® Medical-surgical shoe
Primary DI
00609271790117
Version / Model
MQM1B
Catalog Number
MQM1B; MSM1B-ST
Company Name
DARCO INTERNATIONAL, INC.
Labeler DUNS
184231298
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-08
Public Version
1
Public Version Date
2023-02-16
Public Version Status
New
Public Device Record Key
bf39e26d-a1dc-4c2d-ad1e-4d8551f974ae

Device Description

Men's small Black Square-toe

Device Characteristics

Single Use
Yes
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
KNP ORTHOSIS, CORRECTIVE SHOE

GMDN Terms

Code Name
31041 Orthotic shoe, non-customized

Identifiers

Type ID
Package 20609271790111
Primary 00609271790117
Package 10609271790114