| Primary Device ID | 00850003396323 |
| NIH Device Record Key | a99b2699-5b54-4464-9689-f334af0d8fcd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Twist Kit |
| Version Model Number | TW030 |
| 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 |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com | |
| Phone | (800) 610-3446 |
| tiffini.wittwer@artelon.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003396323 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
[00850003396323]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-19 |
| Device Publish Date | 2024-04-11 |
| 00850003396248 - Twist Kit | 2024-04-19 Flexband 12cm device with anchors and instruments kit |
| 00850003396323 - Twist Kit | 2024-04-19Flexband 30cm device with anchors and instruments kit |
| 00850003396323 - Twist Kit | 2024-04-19 Flexband 30cm device with anchors and instruments kit |
| 00850003396347 - Twist Driver Kit | 2024-04-19 Twist 5.0mm Anchor on Driver. |
| 00850003396330 - Twist Driver Kit | 2024-04-18 Twist 3.85mm Anchor on Driver. |
| 00850003396187 - FlexBand Plus | 2023-06-01 FlexBand Plus 0.5 x 24 Strip with Suture |
| 00850003396200 - DRILL BIT AND GUIDE | 2023-06-01 Cannulated Drill Bit and Guide |
| 10850003396214 - FLEXBAND FIX | 2023-06-01 FLEXBAND and anchor kit with paddle handle |
| 00850003396255 - FlexBand Eyelet Anchor | 2023-06-01 Hex Eyelet Anchor |