FDA UDI In Commercial Distribution 🇺🇸 United States

DJO SURGICAL

DI: 00888912076593 · Model: 410-32-112 · Encore Medical, L.P.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DJO SURGICAL
Primary DI
00888912076593
Version / Model
410-32-112
Company Name
Encore Medical, L.P.
Labeler DUNS
154074504
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-08-07
Public Version
4
Public Version Date
2020-04-06
Public Version Status
Update
Public Device Record Key
bd4d0188-f2e9-49b1-a635-d8acab48aac0

Device Description

NECK, FEMORAL, MODULAR, 32MM 12-¦ CERASIVE TAPER

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented

GMDN Terms

Code Name
33175 Metallic femoral head prosthesis

Identifiers

Type ID
Primary 00888912076593

Premarket Submissions

Submission Number Supplement Number
K000817 000