| Primary Device ID | M68511185SB0 |
| NIH Device Record Key | ce201092-ad56-4992-b311-30d9f0bc18a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Actiflip |
| Version Model Number | 11185SB |
| Catalog Number | 11185SB |
| Company DUNS | 859961950 |
| Company Name | PARCUS MEDICAL LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M68511185SB0 [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 | 2021-08-16 |
| Device Publish Date | 2021-08-06 |
| 00816342024952 | Actiflip Cinch #2 w/ Needles |
| M68511185SB0 | Actiflip w/ #2 Infinity Loop |
| 00816342024969 | Actiflip w/ #2 Infinity Loop |
| 00816342023979 | 3.9 x 12mm AcTiFlip, w/1 infinity loop (wht/blu), w/needle, w/suture threader |
| 00816342023962 | AcTiFlip Cinch #2 w/ Needles |