FDA UDI In Commercial Distribution 🇺🇸 United States

MECRON Wrist Guard L: 23 cm, U: uber 22 cm

DI: 00609271952553 · Model: OSN234102 · DARCO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
MECRON Wrist Guard L: 23 cm, U: uber 22 cm
Primary DI
00609271952553
Version / Model
OSN234102
Catalog Number
OSN234102
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
dc9841a8-f8cd-4012-8d58-686a80306aa6

Device Description

XL Vinly Blue right

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
ILH SPLINT, HAND, AND COMPONENTS

GMDN Terms

Code Name
41459 Wrist/hand orthosis

Identifiers

Type ID
Package 10609271952550
Primary 00609271952553