FDA UDI In Commercial Distribution 🇺🇸 United States

ATTUNE

DI: 10603295383000 · Model: 1549-02-002 · DEPUY (IRELAND)
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ATTUNE
Primary DI
10603295383000
Version / Model
1549-02-002
Catalog Number
154902002
Company Name
DEPUY (IRELAND)
Labeler DUNS
989365556
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-12-05
Public Version
7
Public Version Date
2023-02-03
Public Version Status
Update
Public Device Record Key
fe990dc8-4f2c-4b08-955a-001dd54afb72

Device Description

ATTUNE KNEE SYSTEM REVISION POSTERIOR FEMORAL AUGMENT 8MM CEMENTED SIZE 2

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
NJL Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

GMDN Terms

Code Name
48067 Knee arthroplasty wedge

Identifiers

Type ID
Primary 10603295383000

Customer Contacts