ACURA Stabilization System F004.0332

GUDID B922F004033206

Overhead Reducer-NT

INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

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Primary Device IDB922F004033206
NIH Device Record Keyf6e39c70-fd48-4845-b797-2b577e52d21d
Commercial Distribution StatusIn Commercial Distribution
Brand NameACURA Stabilization System
Version Model NumberF004.0332
Catalog NumberF004.0332
Company DUNS860396609
Company NameINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB922F004033206 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

[B922F004033206]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-17
Device Publish Date2023-08-09

On-Brand Devices [ACURA Stabilization System]

B922A00440000ACURA Stabilization System Threaded Locking Cap
B922A00435000ACURA Stabilization System 5.5 mm x 500 mm TAV Straight Rod
B922A00431250ACURA Stabilization System 5.5 mm x 125 mm TAV Straight Rod
B922A00431000ACURA Stabilization System 5.5 mm x 100 mm TAV Straight Rod
B922A00430750ACURA Stabilization System 5.5 mm x 75 mm TAV Straight Rod
B922A00430650ACURA Stabilization System 5.5 mm x 65 mm TAV Straight Rod
B922A00430550ACURA Stabilization System 5.5 mm x 55 mm TAV Straight Rod
B922A00430450ACURA Stabilization System 5.5 mm x 45 mm TAV Straight Rod
B922A00420600ACURA Stabilization System 5.5 mm x 60 mm TAV Curved Rod
B922A00420550ACURA Stabilization System 5.5 mm x 55 mm TAV Curved Rod
B922A00420500ACURA Stabilization System 5.5 mm x 50 mm TAV Curved Rod
B922A00420450ACURA Stabilization System 5.5 mm x 45 mm TAV Curved Rod
B922A00420400ACURA Stabilization System 5.5 mm x 40 mm TAV Curved Rod
B922A00420350ACURA Stabilization System 5.5 mm x 35 mm TAV Curved Rod
B922A00404550ACURA Stabilization System 7.5 mm x 55 mm Polyaxial Screw
B922A00404500ACURA Stabilization System 7.5 mm x 50 mm Polyaxial Screw
B922A00404450ACURA Stabilization System 7.5 mm x 45 mm Polyaxial Screw
B922A00404400ACURA Stabilization System 7.5 mm x 40 mm Polyaxial Screw
B922A00404350ACURA Stabilization System 7.5 mm x 35 mm Polyaxial Screw
B922A00403600ACURA Stabilization System 6.5 mm x 60 mm Polyaxial Screw
B922A00403550ACURA Stabilization System 6.5 mm x 55 mm Polyaxial Screw
B922A00403500ACURA Stabilization System 6.5 mm x 50 mm Polyaxial Screw
B922A00403450ACURA Stabilization System 6.5 mm x 45 mm Polyaxial Screw
B922A00403400ACURA Stabilization System 6.5 mm x 40 mm Polyaxial Screw
B922A00403350ACURA Stabilization System 6.5 mm x 35 mm Polyaxial Screw
B922A00403300ACURA Stabilization System 6.5 mm x 30 mm Polyaxial Screw
B922A00402550ACURA Stabilization System 5.5 mm x 55 mm Polyaxial Screw
B922A00402500ACURA Stabilization System 5.5 mm x 50 mm Polyaxial Screw
B922A00402450ACURA Stabilization System 5.5 mm x 45 mm Polyaxial Screw
B922A00402400ACURA Stabilization System 5.5 mm x 40 mm Polyaxial Screw
B922A00402350ACURA Stabilization System 5.5 mm x 35 mm Polyaxial Screw
B922A00402300ACURA Stabilization System 5.5 mm x 30 mm Polyaxial Screw
B922A00401400ACURA Stabilization System 4.5 mm x 40 mm Polyaxial Screw
B922A00401350ACURA Stabilization System 4.5 mm x 35 mm Polyaxial Screw
B922A00401300ACURA Stabilization System 4.5 mm x 30 mm Polyaxial Screw
B922A00401250ACURA Stabilization System 4.5 mm x 25 mm Polyaxial Screw
B922F00400080Counter Torque
B922A00421500ACURA Stabilization System 5.5 mm x 150 mm TAV Curved Rod
B922A00421400ACURA Stabilization System 5.5 mm x 140 mm TAV Curved Rod
B922A00421300ACURA Stabilization System 5.5 mm x 130 mm TAV Curved Rod
B922A00421250ACURA Stabilization System 5.5 mm x 125 mm TAV Curved Rod
B922A00421200ACURA Stabilization System 5.5 mm x 120 mm TAV Curved Rod
B922A00421100ACURA Stabilization System 5.5 mm x 110 mm TAV Curved Rod
B922A00421000ACURA Stabilization System 5.5 mm x 100 mm TAV Curved Rod
B922A00420950ACURA Stabilization System 5.5 mm x 95 mm TAV Curved Rod
B922A00420900ACURA Stabilization System 5.5 mm x 90 mm TAV Curved Rod
B922A00420850ACURA Stabilization System 5.5 mm x 85 mm TAV Curved Rod
B922A00420800ACURA Stabilization System 5.5 mm x 80 mm TAV Curved Rod
B922A00420750ACURA Stabilization System 5.5 mm x 75 mm TAV Curved Rod
B922A00420700ACURA Stabilization System 5.5 mm x 70 mm TAV Curved Rod
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