| Primary Device ID | 10850003396214 |
| NIH Device Record Key | 9da1b3f9-ce77-4ad8-95a5-f5b9fd3c8824 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLEXBAND FIX |
| Version Model Number | 51013 |
| 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 | true |
| 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 |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Length | 10 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003396217 [Primary] |
| GS1 | 10850003396214 [Package] Contains: 00850003396217 Package: Carton [5 Units] In Commercial Distribution |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| QWJ | Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
[10850003396214]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-01 |
| Device Publish Date | 2023-05-24 |
| 00850003396248 - Twist Kit | 2024-04-19 Flexband 12cm 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 | 2023-06-01FLEXBAND and anchor kit with paddle handle |
| 10850003396214 - FLEXBAND FIX | 2023-06-01 FLEXBAND and anchor kit with paddle handle |
| 00850003396255 - FlexBand Eyelet Anchor | 2023-06-01 Hex Eyelet Anchor |