WasherCap™ Countersink 8 mm
GUDID 08437019739621
Cannulated instrument used to shape the bone cortex to place de cap of the WasherCap™ Fixation System correctly. The countersink is composed by two parts (the stop and the body). Both parts must be assembled to compose the countersink to ensure that it can be used in accordance with its intended use. The countersink need to be disassembled during its reprocessing in order to facilitate the cleaning process. Prior to the steriliation process, both parts should be assembled again in order to prepare the countersink for its next use.
ABANZA TECNOMED SL.
Surgical countersink, reusable| Primary Device ID | 08437019739621 |
| NIH Device Record Key | 29a5c116-a158-43c7-8dde-2b88f8e19d1f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WasherCap™ Countersink 8 mm |
| 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 |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08437019739621 [Primary] |
| GS1 | 28437019739625 [Package] Package: Primary [1 Units] In Commercial Distribution |
FDA Product Code
| HWW | Countersink |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
[08437019739621]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-09 |
| Device Publish Date | 2023-06-01 |
Devices Manufactured by ABANZA TECNOMED SL.
| 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. |
| 08437019739317 - Sterilization tray | 2023-06-09 Tray supplied with the set containing the above-mentioned instruments, fixed by silicon fasteners. The tray is used to transport |
| 08437019739324 - Handle with AO connection system | 2023-06-09 Accessory handle used to insert instruments with AO connection. |
| 08437019739331 - Countersink tool | 2023-06-09 Tool used to thread and unscrew the top of the countersink body for easy disassembly. |
Trademark Results [WasherCap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WASHERCAP 98047014 not registered Live/Pending |
Abanza Tecnomed, S.L. 2023-06-16 |
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