FDA.reportPublic FDA data

Reprocessed 14mm Drill Bit

Primary DI
B39010900150141
Brand
Reprocessed 14mm Drill Bit
Company
SURETEK MEDICAL
Model
10-90-015-014
Published
2021-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
B39010900150141PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-useA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785616934
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B390197230FLA1Reprocessed 4mm EndoScrub Sheath, 45 deg, K Storz197230FLA2026-04-30
B39019120501Reprocessed 4mm EndoScrub Sheath, 0 deg19-120502024-06-19
B390197230BVA1Reprocessed 4mm EndoScrub Sheath, 30 deg197230BVA2022-12-26
B3901912050T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing19-12050T2023-12-27
B39019120271Reprocessed 2.7mm EndoScrub Sheath, 30 deg19-120272021-06-16
B3901912101Reprocessed 4mm EndoScrub Sheath, 30 deg1912102021-06-16
B3901912131Reprocessed 4mm EndoScrub Sheath, 45 deg1912132021-06-16
B3901912201Reprocessed 4mm EndoScrub Sheath, 70 deg1912202021-06-16
B3901912000T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing19-12000T2021-06-15
B3901912001Reprocessed 4mm EndoScrub Sheath, 0 deg1912002021-06-15
B390191200T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing191200T2021-06-15
B39019120101Reprocessed 4mm EndoScrub Sheath, 30 deg19-120102021-06-15
B39019120131Reprocessed 4mm EndoScrub Sheath, 45 deg, K Storz19-120132021-06-15
B39019120201Reprocessed 4mm EndoScrub Sheath, 70 deg19-120202021-06-15
B3901912000Reprocessed Endoscrub Sheath, 4mm, 0 deg19-120002021-06-14
B39016005391Reprocessed Shaver Blade Straight 3.5mm Double Serrated16005392025-12-09
B39016005741Reprocessed Shaver Blade Curved, 60 Deg, Double Serrated16005742025-12-09
B3901884002HRT1Reprocessed 4.0mm Serrated Blade, Rotatable, with Tubing18-84002HRT2025-12-09
B39062901120331Reprocessed 3mm Straight Shaver Blade6290-112-0332025-12-09
B3906290112040121Reprocessed 4mm Angled 12 Degree Shaver Blade6290-112-040-122025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
08053782783724BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-04-29
08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386744277Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386742327Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742341Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742358Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742365Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742372Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742389Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742396Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742402Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386747957Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-10-27
08053782780464BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
08053782780471BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
G79151202112817G0WishFIXRed Star Contract Manufacturing Inc.HTW2025-10-06
09120125220044Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220051Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220068Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220075Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220082Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220099Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220105Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220112Shark Screw® drillsurgebright GmbHHTW2025-09-16
08809416065601Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065618Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065625Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066905Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066912Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416068671Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24