MicroFrance® - RETRACTOR CP21-3 140MM 3 PRONGS - INTEGRA MICROFRANCE

Duns Number:276593071

Device Description: RETRACTOR CP21-3 140MM 3 PRONGS

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More Product Details

Catalog Number

CP21-3

Brand Name

MicroFrance®

Version/Model Number

CP21-3

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

GAD

Product Code Name

RETRACTOR

Device Record Status

Public Device Record Key

9b58721a-eed2-437b-aedc-8ff606ed4653

Public Version Date

October 03, 2022

Public Version Number

4

DI Record Publish Date

June 02, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA MICROFRANCE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1433
2 A medical device with a moderate to high risk that requires special controls. 879