Primary Device ID | 03760177047044 |
NIH Device Record Key | e8535be7-e5bc-4598-9e1f-6c2a5637bb22 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OSSEOFIX + |
Version Model Number | PRECISION PACK |
Catalog Number | 21302 |
Company DUNS | 764746723 |
Company Name | TEKNIMED |
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 | 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 |
---|---|
GS1 | 03760177047044 [Primary] |
OAR | Injector, Vertebroplasty (Does Not Contain Cement) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-15 |
Device Publish Date | 2020-10-07 |
03760177046337 | 21390 |
03760177047044 | PRECISION PACK |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OSSEOFIX + 77517419 3693779 Dead/Cancelled |
Alphatec Spine, Inc. 2008-07-08 |