| Primary Device ID | 00850003396088 |
| NIH Device Record Key | 087346a4-2e7f-44d4-afe1-f4839f5f356c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FlexBand Plus |
| Version Model Number | 41052 |
| 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 | false |
| 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 | 00850003396088 [Primary] |
| FTL | Mesh, Surgical, Polymeric |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-06 |
| Device Publish Date | 2019-12-27 |
| 00850003396101 | FlexBand Plus 0.3 x 32 Strip with Suture |
| 00850003396095 | FlexBand Plus 0.3 x 8 Strip with Suture |
| 00850003396088 | FlexBand Plus 0.3 x 16 Strip with Suture |
| 00850003396071 | FlexBand Plus 0.5 x 8 Strip with Suture |
| 00850003396064 | FlexBand Plus 0.5 x 16 Strip with Suture |
| 00850003396057 | FLexBand Plus 0.7 x 8 Strip with Suture |
| 00850003396040 | FlexBand Plus 0.7 x 16 Strip with Suture |
| 00850003396033 | FlexBand Plus 0.5 x 32 Strip with Suture |
| 00850003396026 | FLexBand Plus 0.7 x 32 Strip with Suture |
| 00850003396187 | FlexBand Plus 0.5 x 24 Strip with Suture |