FDA.reportPublic FDA data

Shark Screw® driver

Primary DI
09120125220228
Brand
Shark Screw® driver
Company
surgebright GmbH
Model
USCDRV
Device description
Driver for Shark Screw® cut
Published
2025-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120125220228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120125220228091201252202289120125220228

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
300487622
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120125220310Shark Screw® GuidewireUSCGW122026-01-09
09120125220297Shark Screw® PinUSCP3516C2026-01-08
09120125220303Shark Screw® PinUSCP5018S2026-01-08
09120125220259Shark Screw® driver aclSCDRVacl2026-04-30
09120125220273Shark Screw® drillSCDR50L2026-04-30
09120125220280Shark Screw® tapSCTA50L2026-04-30
09120125220037Shark Screw® couplingC-08.002025-09-16
09120125220044Shark Screw® drillSCDR352025-09-16
09120125220051Shark Screw® drillSCDR402025-09-16
09120125220068Shark Screw® drillSCDR45L2025-09-16
09120125220075Shark Screw® drillSCDR50L2025-09-16
09120125220082Shark Screw® drillUSCDR352025-09-16
09120125220099Shark Screw® drillUSCDR402025-09-16
09120125220105Shark Screw® drillUSCDR45L2025-09-16
09120125220112Shark Screw® drillUSCDR50L2025-09-16
09120125220129Shark Screw® handleUSCHB2025-09-16
09120125220136Shark Screw® tapUSCTA352025-09-16
09120125220143Shark Screw® tapUSCTA402025-09-16
09120125220150Shark Screw® tapUSCTA45L2025-09-16
09120125220167Shark Screw® tapUSCTA50L2025-09-16

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Primary DI, Brand, Company table
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00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191982Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
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10887587078557NASynthes GmbHHXX2026-07-24
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00888118154644LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
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00888118154675LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154682LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154699LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154705LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154712LEVEL ONEKLS-Martin L.P.HXX2026-07-21
00199150072323Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-19