Primary Device ID | 00822409007585 |
NIH Device Record Key | c247a1ad-9b88-4b26-87a1-d96135381e1f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KASM |
Version Model Number | 669-2058 |
Company DUNS | 876542390 |
Company Name | Ortho Development Corporation |
Device Count | 1 |
DM Exempt | true |
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 | 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 |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com |
Length | 39 Millimeter |
Length | 39 Millimeter |
Length | 39 Millimeter |
Length | 39 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00822409007585 [Primary] |
MBB | BONE CEMENT, ANTIBIOTIC |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-09-23 |
Device Publish Date | 2015-08-31 |
00822409007608 | Large 52A/P x 81M/L Tibial Spacer Mold |
00822409007592 | Medium 45A/P x 70M/L Tibial Spacer Mold |
00822409007585 | Small 39A/P x 58M/L Tibial Spacer Mold |
00822409007578 | Large 53A/P x 75M/L Femoral Spacer Mold |
00822409007561 | Medium 44A/P x 67M/L Femoral Spacer Mold |
00822409007554 | Small 37A/P x 60M/L Femoral Spacer Mold |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() KASM 85052135 3992272 Live/Registered |
Ortho Development Corporation 2010-06-01 |