FDA UDI In Commercial Distribution 🇺🇸 United States

TaperFit Cemented Hip System

DI: 05055343892602 · Model: 588.6503 · CORIN LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TaperFit Cemented Hip System
Primary DI
05055343892602
Version / Model
588.6503
Catalog Number
588.6503
Company Name
CORIN LTD
Labeler DUNS
295437313
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-21
Public Version
1
Public Version Date
2018-09-21
Public Version Status
New
Public Device Record Key
78168b9a-514d-4498-b3fc-169bca3a9165

Device Description

Size 3 50mm Offset Rasp

Device Characteristics

Single Use
No
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
No
Has Donation ID
No

Sterilization

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

Product Codes

Code Name
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
JDG Prosthesis, hip, femoral component, cemented, metal

GMDN Terms

Code Name
36167 Orthopaedic broach

Identifiers

Type ID
Primary 05055343892602

Customer Contacts

Phone
+441285659866 ext. 2118

Premarket Submissions

Submission Number Supplement Number
K142761 000