| Primary Device ID | 09120125220310 |
| NIH Device Record Key | 8c277706-b2d0-4b1f-85f2-c9c784e57b4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shark Screw® Guidewire |
| Version Model Number | USCGW12 |
| Company DUNS | 300487622 |
| Company Name | surgebright GmbH |
| Device Count | 10 |
| DM Exempt | false |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09120125220310 [Primary] |
| GS1 | 09120125220327 [Unit of Use] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
[09120125220310]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-19 |
| Device Publish Date | 2026-01-09 |
| 09120125220310 - Shark Screw® Guidewire | 2026-01-19Shark Screw® Guidewire, Ø 1,2 mm |
| 09120125220310 - Shark Screw® Guidewire | 2026-01-19 Shark Screw® Guidewire, Ø 1,2 mm |
| 09120125220297 - Shark Screw® Pin | 2026-01-16 Shark Screw® Pin, Ø 1,6 mm, compression length 35mm |
| 09120125220303 - Shark Screw® Pin | 2026-01-16 Shark Screw® Pin, Ø 1,8 mm, compression length 50mm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SHARK SCREW 98258811 not registered Live/Pending |
surgebright GmbH 2023-11-07 |