ACURA Stabilization System - Rigid Screw Driver (NT) F004.0319

GUDID B922F00403190

Rigid Screw Driver - NT

INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Surgical screwdriver, reusable
Primary Device IDB922F00403190
NIH Device Record Key825bf150-1db3-4e3f-b07a-7cc624bbbc5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameACURA Stabilization System - Rigid Screw Driver (NT)
Version Model NumberF004.0319
Catalog NumberF004.0319
Company DUNS860396609
Company NameINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB922F00403190 [Primary]

FDA Product Code

HXXScrewdriver

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

[B922F00403190]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-19
Device Publish Date2022-10-11

Devices Manufactured by INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

B922A00470200 - ACURA Stabilization System2026-02-12 ACURA Stabilization System Ø 4.0 x 20 mm Polyaxial Screw - NT
B922A00470250 - ACURA Stabilization System2026-02-12 ACURA Stabilization System Ø 4.0 x 25 mm Polyaxial Screw - NT
B922A00470300 - ACURA Stabilization System2026-02-12 ACURA Stabilization System Ø 4.0 x 30 mm Polyaxial Screw - NT
B922A00470350 - ACURA Stabilization System2026-02-12 ACURA Stabilization System Ø 4.0 x 35 mm Polyaxial Screw - NT
B922A00470400 - ACURA Stabilization System2026-02-12 ACURA Stabilization System Ø 4.0 x 40 mm Polyaxial Screw - NT
B922A00470450 - ACURA Stabilization System2026-02-12 ACURA Stabilization System Ø 4.0 x 45 mm Polyaxial Screw - NT
B922A00471250 - ACURA Stabilization System2026-02-12 ACURA Stabilization System Ø 4.5 x 25 mm Polyaxial Screw - NT
B922A0047130 - ACURA Stabilization System2026-02-12 ACURA Stabilization System Ø 4.5 x 30 mm Polyaxial Screw - NT
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.