FDA UDI In Commercial Distribution 🇺🇸 United States

LPS

DI: 10603295079293 · Model: 1987-26-414 · DEPUY ORTHOPAEDICS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LPS
Primary DI
10603295079293
Version / Model
1987-26-414
Catalog Number
198726414
Company Name
DEPUY ORTHOPAEDICS, INC.
Labeler DUNS
080506581
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-24
Public Version
4
Public Version Date
2020-04-20
Public Version Status
Update
Public Device Record Key
f92ec3f5-d416-4da1-b13f-902ae1de59d5

Device Description

LPS STEM - STRAIGHT 15.5mm x 125mm POROUS

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
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented

GMDN Terms

Code Name
48066 Knee femur stem prosthesis

Identifiers

Type ID
Primary 10603295079293

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K003182 000
K033959 000