Tissue Punch - 5mm Tissue Punch - OCO BIOMEDICAL INC

Duns Number:094146123

Device Description: 5mm Tissue Punch

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More Product Details

Catalog Number

0065

Brand Name

Tissue Punch

Version/Model Number

5mm Tissue Punch

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DZN

Product Code Name

Instruments, Dental Hand

Device Record Status

Public Device Record Key

7180360e-5429-431a-b3be-1c0395179b7c

Public Version Date

January 09, 2020

Public Version Number

4

DI Record Publish Date

April 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OCO BIOMEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 76
2 A medical device with a moderate to high risk that requires special controls. 348