Primary Device ID | M684ESC160751 |
NIH Device Record Key | b11ea261-1246-48f8-a802-33b7d32e8f74 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EVOLUTION® |
Version Model Number | ESC16075 |
Catalog Number | ESC16075 |
Company DUNS | 079118736 |
Company Name | Microport Orthopedics Inc. |
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 | false |
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 |
Phone | +1(866)872-0211 |
Stephen.Weaver@ortho.microport.com |
Outer Diameter | 16 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M684ESC160751 [Primary] |
JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-04-20 |
Device Publish Date | 2017-03-27 |