| Primary Device ID | 08437019739331 |
| NIH Device Record Key | 4ec89cb1-5d63-4d30-8d29-cecd58d90219 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Countersink tool |
| Version Model Number | 21 |
| Company DUNS | 465714287 |
| Company Name | ABANZA TECNOMED SL. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08437019739331 [Primary] |
| GS1 | 28437019739335 [Package] Package: Primary [1 Units] In Commercial Distribution |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
[08437019739331]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-09 |
| Device Publish Date | 2023-06-01 |
| 28437019739861 - WasherCap™ Fixation System 11mm | 2025-03-18 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue |
| 28437019739892 - WasherCap Mini Fixation system 3.5mm | 2025-03-05 The WasherCap™ Mini Fixation System is a medical device designed for fixation of suture/tape (soft tissue) to bone during surg |
| 28437019739908 - WasherCap Mini Fixation system 4.5mm | 2025-03-05 The WasherCap™ Mini Fixation System is a medical device designed for fixation of suture/tape (soft tissue) to bone during surg |
| 08437019739812 - WasherCap™ Fixation System 7mm | 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue |
| 08437019739829 - WasherCap™ Fixation System 8mm | 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue |
| 08437019739836 - WasherCap™ Fixation System 9mm | 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue |
| 08437019739843 - WasherCap™ Fixation System 10mm | 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue |
| 08437019739164 - WasherCap™ Screwdriver | 2023-06-09 Instrument used to screw the “screw-washer” assembly to the cap, locking the tendon against the locking corridor of the cap. |