Primary Device ID | EPIS18100PF0 |
NIH Device Record Key | f8a68eb5-56f7-4c50-95d5-2149e5419632 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Episealer Knee Revision Guide |
Version Model Number | First version |
Catalog Number | 18100PF |
Company DUNS | 352393402 |
Company Name | Episurf Operations AB |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | EPIS18100PF0 [Primary] |
KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-01 |
Device Publish Date | 2023-07-24 |
EPIS18100PF0 - Episealer Knee Revision Guide | 2023-08-01 |
EPIS18100PF0 - Episealer Knee Revision Guide | 2023-08-01 |
EPIS31120PF0 - Femoral Component | 2023-08-01 |
EPIS31125PF0 - Femoral Component | 2023-08-01 |
EPIS31129PF0 - Femoral Component | 2023-08-01 |
EPIS32120PF0 - Femoral Epidrill | 2023-08-01 |
EPIS32125PF0 - Femoral Epidrill | 2023-08-01 |
EPIS32129PF0 - Femoral Epidrill | 2023-08-01 |
EPIS33120PF0 - Femoral Drilling Socket | 2023-08-01 |