Plate Holder, Small - Plate Holder, Small - INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Duns Number:860396609

Device Description: Plate Holder, Small

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More Product Details

Catalog Number

F007.0001

Brand Name

Plate Holder, Small

Version/Model Number

F007.0001

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

HXK

Product Code Name

Holder, Needle; Orthopedic

Device Record Status

Public Device Record Key

55347b16-a8ac-4ee3-b819-28da74a6912f

Public Version Date

April 21, 2021

Public Version Number

2

DI Record Publish Date

January 20, 2021

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