| Primary Device ID | 00850003396330 |
| NIH Device Record Key | ae0575d5-3b46-40aa-aca0-8d4fc8832524 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Twist Driver Kit |
| Version Model Number | TA385 |
| Catalog Number | TA385 |
| Company DUNS | 066284070 |
| Company Name | Artelon |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| 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 |
|---|---|
| GS1 | 00850003396330 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
[00850003396330]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-18 |
| Device Publish Date | 2024-04-10 |
| 00850003396330 | Twist 3.85mm Anchor on Driver. |
| 00850003396347 | Twist 5.0mm Anchor on Driver. |