FDA UDI In Commercial Distribution 🇺🇸 United States

KineMatch® PFR System

DI: 00818720011240 · Model: Custom 100 · Kinamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
KineMatch® PFR System
Primary DI
00818720011240
Version / Model
Custom 100
Catalog Number
Custom 100
Company Name
Kinamed, Inc.
Labeler DUNS
184896645
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-11-04
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
4b6f8bb7-787c-4238-baf4-f4c696d8c98a

Device Description

Custom PFR Primary Left

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
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KRR PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

GMDN Terms

Code Name
58227 Patellofemoral joint prosthesis

Identifiers

Type ID
Primary 00818720011240