FDA UDI In Commercial Distribution 🇺🇸 United States

MobileLink Acetabular Cup System

DI: 04026575209354 · Model: 183-920/01 · WALDEMAR LINK GmbH & Co. KG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MobileLink Acetabular Cup System
Primary DI
04026575209354
Version / Model
183-920/01
Company Name
WALDEMAR LINK GmbH & Co. KG
Labeler DUNS
315675488
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-26
Public Version
1
Public Version Date
2023-02-03
Public Version Status
New
Public Device Record Key
ef75392b-b7cd-4249-b20b-d578ff98b1ba

Device Description

Dual Mobility Insert

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
Yes
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
OQG Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

GMDN Terms

Code Name
48056 Metallic acetabular liner

Identifiers

Type ID
Primary 04026575209354

Premarket Submissions

Submission Number Supplement Number
K200607 000