Alignment Jig F003.0021

GUDID B922F00300210

Alignment Jig

INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Internal spinal fixation procedure kit, reusable
Primary Device IDB922F00300210
NIH Device Record Key17ace83a-0580-44a0-bfc8-05b962575d75
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlignment Jig
Version Model NumberF003.0021
Catalog NumberF003.0021
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB922F00300210 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

[B922F00300210]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-09
Device Publish Date2023-11-01

Devices Manufactured by INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

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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
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