FDA UDI In Commercial Distribution 🇺🇸 United States

DJO SURGICAL

DI: 00888912100151 · Model: 932-36-280 · Encore Medical, L.P.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DJO SURGICAL
Primary DI
00888912100151
Version / Model
932-36-280
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
2019-07-03
Public Version Status
Update
Public Device Record Key
ceae11e6-9080-4da8-9015-d931bfc59c96

Device Description

LINER, ACETABULAR, HOODED, NEUTRAL, 10°, HXL/FMP, 36MM ID, MP15

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
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
Yes
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
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

GMDN Terms

Code Name
43168 Non-constrained polyethylene acetabular liner

Identifiers

Type ID
Primary 00888912100151

Premarket Submissions

Submission Number Supplement Number
K130365 000