FDA UDI In Commercial Distribution 🇺🇸 United States

EMPHASYS

DI: 10603295514985 · Model: 4800-00-410 · DEPUY (IRELAND)
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EMPHASYS
Primary DI
10603295514985
Version / Model
4800-00-410
Catalog Number
480000410
Company Name
DEPUY (IRELAND)
Labeler DUNS
989365556
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-09-20
Public Version
2
Public Version Date
2023-05-08
Public Version Status
Update
Public Device Record Key
8c795c49-3b55-431d-ac32-7f692f283731

Device Description

EMPHASYS ACETABULAR ALUMINUM CADDY ODD TRIAL SHELL 43mm - 65mm

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
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 10603295514985

Customer Contacts