FDA UDI In Commercial Distribution 🇺🇸 United States

n/a

DI: 04048844235239 · Model: 57201216 · implantcast GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
n/a
Primary DI
04048844235239
Version / Model
57201216
Company Name
implantcast GmbH
Labeler DUNS
324369826
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-09-24
Public Version
2
Public Version Date
2025-06-09
Public Version Status
Update
Public Device Record Key
e2edcf17-25b1-4e9f-a7e1-8a8f30b67068

Device Description

screw for MK spacer

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

GMDN Terms

Code Name
63998 Implantable orthopaedic/craniofacial device connection screw

Identifiers

Type ID
Primary 04048844235239