FDA UDI In Commercial Distribution 🇺🇸 United States

DONJOY PERFORMANCE

DI: 00190446241256 · Model: DP171KW01-SGR-S,M · DJO, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DONJOY PERFORMANCE
Primary DI
00190446241256
Version / Model
DP171KW01-SGR-S,M
Company Name
DJO, LLC
Labeler DUNS
081840873
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-05-20
Public Version
3
Public Version Date
2022-08-30
Public Version Status
Update
Public Device Record Key
9dc3eb50-52d5-4dae-af58-599083753d92

Device Description

BIONIC COMFORT HINGED KNEE, SLIME GREEN, SMALL/MEDIUM

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
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
ITQ JOINT, KNEE, EXTERNAL BRACE

GMDN Terms

Code Name
41065 Knee support orthosis

Identifiers

Type ID
Primary 00190446241256