| Primary Device ID | 00810027270405 |
| NIH Device Record Key | d9a633c1-e438-4a4b-b73c-43c1eb61e958 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3.5 x 15.5mm Citrefix Implant |
| Version Model Number | 30-110-7035 |
| Company DUNS | 074645634 |
| Company Name | Acuitive Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | 201-661-2680 |
| mpoggie@acuitivetech.com | |
| Phone | 201-661-2680 |
| mpoggie@acuitivetech.com | |
| Phone | 201-661-2680 |
| mpoggie@acuitivetech.com | |
| Phone | 201-661-2680 |
| mpoggie@acuitivetech.com | |
| Phone | 201-661-2680 |
| mpoggie@acuitivetech.com | |
| Phone | 201-661-2680 |
| mpoggie@acuitivetech.com | |
| Phone | 201-661-2680 |
| mpoggie@acuitivetech.com | |
| Phone | 201-661-2680 |
| mpoggie@acuitivetech.com | |
| Phone | 201-661-2680 |
| mpoggie@acuitivetech.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810027270405 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-25 |
| Device Publish Date | 2022-07-15 |