Biopsy Punch, Sterile, 1.5 mm ,White - DYNAREX CORPORATION

Duns Number:008124539

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More Product Details

Catalog Number

-

Brand Name

Biopsy Punch, Sterile, 1.5 mm ,White

Version/Model Number

4086

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

Yes

Prescription Use (Rx)

-

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

LRY

Product Code Name

Punch, Surgical

Device Record Status

Public Device Record Key

d8edea5c-64c0-46f9-8a39-0f30bf08ae69

Public Version Date

May 31, 2022

Public Version Number

1

DI Record Publish Date

May 23, 2022

Additional Identifiers

Package DI Number

00840117322844

Quantity per Package

24

Contains DI Package

00840117322707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2