ACURA Stabilization System - Straight Lenke Probe - Straight Lenke Probe - INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Duns Number:860396609

Device Description: Straight Lenke Probe

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More Product Details

Catalog Number

F004.0115

Brand Name

ACURA Stabilization System - Straight Lenke Probe

Version/Model Number

F004.0115

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HXB

Product Code Name

Probe

Device Record Status

Public Device Record Key

824f4030-86fa-4a88-9e72-3eb403cb53fc

Public Version Date

March 29, 2022

Public Version Number

1

DI Record Publish Date

March 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 55
2 A medical device with a moderate to high risk that requires special controls. 124