FDA.report

Rod Cutter

Primary DI
B922F00400170
Brand
Rod Cutter
Company
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
Model
F004.0017
Catalog number
F004.0017
Device description
Acura Stabilization System - Rod Cutter
Published
2022-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HXZCutter, Wire

Product Code Classifications

CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B922F00400170PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1214-972-8683info@indiusmedical.com

Regulatory Flags

DUNS number
860396609
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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

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