MicroFrance® - SCAPEL HANDLE CP821B 100MM - INTEGRA MICROFRANCE

Duns Number:276593071

Device Description: SCAPEL HANDLE CP821B 100MM

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More Product Details

Catalog Number

CP821B

Brand Name

MicroFrance®

Version/Model Number

CP821B

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

GDZ

Product Code Name

HANDLE, SCALPEL

Device Record Status

Public Device Record Key

0edca9f5-13c8-45da-9bb3-f7ed2a2aad57

Public Version Date

October 04, 2022

Public Version Number

4

DI Record Publish Date

September 29, 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