Primary Device ID | M9701101020000 |
NIH Device Record Key | 1fe9d257-c97c-484f-949a-d0db056bdd28 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ExoShape |
Version Model Number | 1101-02-000 |
Company DUNS | 601306413 |
Company Name | Medshape, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 | M9701101020000 [Primary] |
HIBCC | M97013000102404 [Direct Marking] |
KDD | Kit, Surgical Instrument, Disposable |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-02-06 |
Device Publish Date | 2015-12-15 |
M9701101020000 | ACL Procedure Pack, Sterile |
M970110000093007 | EXOSHAPE Deployment Cartridge, 9mm x 30mm, Angled-Back |
M970110000083006 | EXOSHAPE Deployment Cartridge, 8mm x 30mm, Angled-Back |
M970110000073005 | EXOSHAPE Deployment Cartridge, 7mm x 30mm, Angled-Back |
M970110000062800 | EXOSHAPE Deployment Cartridge, 6mm x 28mm, Angled-Back |
M970110100123002 | EXOSHAPE Deployment Cartridge, 12mm x 30mm, Angled, Knurled |
M970110100093008 | EXOSHAPE Deployment Cartridge, 9mm x 30mm, Angled, Knurled |
M970110100083007 | EXOSHAPE Deployment Cartridge, 8mm x 30mm, Angled, Knurled |
M970110100073006 | EXOSHAPE Deployment Cartridge, 7mm x 30mm, Angled, Knurled |
M970110000123001 | EXOSHAPE Deployment Cartridge, 12mm x 30mm, Angled-Back |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EXOSHAPE 85125012 3982761 Live/Registered |
CONMED CORPORATION 2010-09-08 |