IMPIX-C - SMALL CURETTE - MEDICREA INTERNATIONAL

Duns Number:383228632

Device Description: SMALL CURETTE

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More Product Details

Catalog Number

-

Brand Name

IMPIX-C

Version/Model Number

MS6010042

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

HTF

Product Code Name

Curette

Device Record Status

Public Device Record Key

44d179f1-4542-45a8-b5b8-668de02052d2

Public Version Date

May 23, 2022

Public Version Number

6

DI Record Publish Date

January 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICREA INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1328
2 A medical device with a moderate to high risk that requires special controls. 3995