FDA.reportPublic FDA data

Driver with Sleeve

Primary DI
B922F00300180
Brand
Driver with Sleeve
Company
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
Model
F003.0018
Catalog number
F003.0018
Device description
Driver with Sleeve
Published
2021-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
B922F00300180PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1636-825-1231info@indiusmedical.com

Regulatory Flags#

DUNS number
860396609
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B922F004800208ACURA Stabilization SystemF004.8002F004.80022026-03-11
B922F005001505Acura Stabilization SystemF005.0015F005.00152026-03-11
B922F005001707ACURA Stabilization SystemF005.0017F005.00172026-03-11
B922F005001808ACURA Stabilization SystemF005.0018F005.00182026-03-11
B922F005003608ACURA Stabilization SystemF005.0036F005.00362026-03-11
B922F005003709ACURA Stabilization SystemF005.0037F005.00372026-03-11
B922F00500380ACURA Stabilization SystemF005.0038F005.00382026-03-11
B922F00500390ACURA Stabilization SystemF005.0039F005.00392026-03-11
B922IMDT00490ACURA Stabilization System IMDT.0049IMDT.00492026-03-11
B922F005000100Guidewire ( Non-Threaded)F005.0001F005.00012026-03-09
B922F005000201Access Needle (8 Gauge)F005.0002F005.00022026-03-09
B922F005000706Rod CaliperF005.0007F005.00072026-03-09
B922A00470200ACURA Stabilization SystemA004.7020A004.70202026-02-04
B922A00470250ACURA Stabilization SystemA004.7025A004.70252026-02-04
B922A00470300ACURA Stabilization SystemA004.7030A004.70302026-02-04
B922A00470350ACURA Stabilization SystemA004.7035A004.70352026-02-04
B922A00470400ACURA Stabilization SystemA004.7040A004.70402026-02-04
B922A00470450ACURA Stabilization SystemA004.7045A004.70452026-02-04
B922A00471250ACURA Stabilization SystemA004.7125A004.71252026-02-04
B922A0047130ACURA Stabilization SystemA004.7130A004.71302026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165208Tendonesis Chamfer ReamerSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
G791SDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
09120125220228Shark Screw® driversurgebright GmbHHXX2025-09-16
08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024248SignexOSTEONIC CO.,Ltd.HXX2025-06-24