FDA.reportPublic FDA data

Shark Screw® drill

Primary DI
09120125220044
Brand
Shark Screw® drill
Company
surgebright GmbH
Model
SCDR35
Device description
Drill for Shark Screw 3.5 / cannulated / Ø2.85 mm
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120125220044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120125220044091201252200449120125220044

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, reusableA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). 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
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
09120125220174Shark Screw® tapSCTA352025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886913330Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HTW2026-10-15
00889795150141APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150158APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150165APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150172APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150189APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150196APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150202APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150219APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150226APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150233APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150240APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150257APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795151728APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00190446960324DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960331DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960348DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960409DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960416DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00889024715271Affixus®Zimmer, Inc.HTW2026-10-06
10886982345431VOLTSynthes GmbHHTW2026-09-25
10886982345479VOLTSynthes GmbHHTW2026-09-25
00888867574540Arthrex®ARTHREX, INC.HTW2026-09-18
00888867574557Arthrex®ARTHREX, INC.HTW2026-09-18
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
00884450681381Preston™Merit Medical Systems, Inc.HTW2026-08-21
00884450681398Preston™Merit Medical Systems, Inc.HTW2026-08-21