FDA UDI In Commercial Distribution 🇺🇸 United States

NEXGEN® TRABECULAR METAL®

DI: 00889024465664 · Model: 00-5878-065-29 · Zimmer, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NEXGEN® TRABECULAR METAL®
Primary DI
00889024465664
Version / Model
00-5878-065-29
Catalog Number
00-5878-065-29
Company Name
Zimmer, Inc.
Labeler DUNS
056038268
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-08
Public Version
7
Public Version Date
2023-03-17
Public Version Status
Update
Public Device Record Key
7be461bb-a41e-47c2-9a2c-90ef48ae6744

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
No
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
JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MBH PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

GMDN Terms

Code Name
34192 Metal-backed patella prosthesis

Identifiers

Type ID
Primary 00889024465664

Customer Contacts

Device Sizes

Type Value Unit Text
Device Size Text, specify SIZE 29 MM DIA., THICKNESS 10 MM