FDA UDI In Commercial Distribution 🇺🇸 United States

Continuum® Trilogy® Allofit® Longevity®

DI: 00889024151925 · Model: 00-8758-016-32 · Zimmer, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Continuum® Trilogy® Allofit® Longevity®
Primary DI
00889024151925
Version / Model
00-8758-016-32
Catalog Number
00-8758-016-32
Company Name
Zimmer, Inc.
Labeler DUNS
056038268
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-17
Public Version
5
Public Version Date
2020-08-31
Public Version Status
Update
Public Device Record Key
1ec2b449-9bd7-45d6-a877-ab31eeaafabd

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
MR Conditional
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
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

GMDN Terms

Code Name
44362 Constrained polyethylene acetabular liner

Identifiers

Type ID
Primary 00889024151925

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K101730 000
K200823 000

Device Sizes

Type Value Unit Text
Lumen/Inner Diameter 32 Millimeter
Device Size Text, specify Size OO