| Primary Device ID | 00889795057242 |
| NIH Device Record Key | 8e29a7d8-ad69-4d6a-9284-7fae46f715d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TenoTac Soft Tissue Fixation System |
| Version Model Number | P42-935-0002 |
| Catalog Number | P42-935-0002 |
| Company DUNS | 042961576 |
| Company Name | PARAGON 28, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889795057242 [Primary] |
| HTJ | GAUGE, DEPTH |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889795057242]
Moist Heat or Steam Sterilization
[00889795057242]
Moist Heat or Steam Sterilization
[00889795057242]
Moist Heat or Steam Sterilization
[00889795057242]
Moist Heat or Steam Sterilization
[00889795057242]
Moist Heat or Steam Sterilization
[00889795057242]
Moist Heat or Steam Sterilization
[00889795057242]
Moist Heat or Steam Sterilization
[00889795057242]
Moist Heat or Steam Sterilization
[00889795057242]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-15 |
| Device Publish Date | 2022-08-05 |
| 00889795053671 | K-Wire, Single Ended Trocar Tip, SMOOTH, 0.9 x 100mm |
| 00889795053640 | TenoTac Female Implant Depth Gauge |
| 00889795053633 | TenoTac Female Implant Driver, T15 |
| 00889795053626 | TenoTac Male Implant Inserter, T15 |
| 00889795053602 | TenoTac Female, LONG 4.5 x 2.2 x 10mm |
| 00889795053596 | TenoTac Female, MED 4.5 x 2.2 x 7.5mm |
| 00889795053589 | TenoTac Female, SHORT, 4.5 x 2.2 x 5mm |
| 00889795053572 | TenoTac Male, 6 x 2.2 x 6.5mm |
| 00889795053565 | TenoTac Caddy Lid |
| 00889795053558 | TenoTac Caddy Base |
| 00889795053619 | TenoTac ø2.8mm Cannulated Drill, ø6.0mm Countersink, 20mm Long |
| 00889795114549 | STERILE-Male Implant |
| 00889795114532 | STERILE-Female Implant, Long |
| 00889795114525 | STERILE-Female Implant, Short |
| 00889795114518 | TenoTac Sterile Kit System, Ø8mm x 2.2mm x 7.5mm |
| 00889795100023 | TenoTac Caddy Lid |
| 00889795100016 | TenoTac Caddy Base |
| 00889795057280 | (Extra Long) TenoTac Female Implant ø4.5mm x 2.2mm x 12.5mm Long |
| 00889795057273 | TenoTac Male Implant ø8mm x 2.2mm x 10mm Long |
| 00889795057266 | TenoTac Single Use ø2.8mm Cannulated Drill, ø8.0mm Countersink, 25mm Long |
| 00889795057259 | TenoTac Single Use ø2.8mm Cannulated Drill, ø6.0mm Countersink, 20mm Long |
| 00889795057242 | TenoTac Single Use Female Implant Length Gauge 1st |
| 00889795057235 | TenoTac Single Use Female Implant Length Gauge 2nd, 3rd, 4th |
| 00889795057228 | TenoTac Single Use Female Implant Driver, T15 |
| 00889795057211 | TenoTac Single Use Male Implant Inserter T15 Driver, 40mm Inserter Wire |
| 00889795057204 | (Extra Long) TenoTac Female Implant ø4.5mm x 2.2mm x 12.5mm Long Sterile Packaged |
| 00889795057198 | (Long) TenoTac Female Implant ø4.5mm x 2.2mm x 10mm Long Sterile Packaged |
| 00889795057181 | (Medium) TenoTac Female Implant ø4.5mm x 2.2mm x 7.5mm Long Sterile Packaged |
| 00889795057174 | (Short) TenoTac Female Implant ø4.5mm x 2.2mm x 5mm Long Sterile Packaged |
| 00889795057167 | TenoTac Male Implant ø8mm x 2.2mm x 10mm Long Sterile Packaged |
| 00889795057150 | TenoTac Male Implant ø6mm x 2.2mm x 6.5mm Long Sterile Packaged |
| 00889795057143 | TenoTac Sterile Kit 1st Digit BOM (diameter 8.0mm male x 10.0mm long) |
| 00889795057136 | TenoTac Sterile Kit 2nd, 3rd, 4th Digit BOM (diameter 6.0mm male x 6.5mm long) |