CROC Multiple Sample Single-Use Biopsy Forceps - Single-Use Multiple Sample Biopsy Forceps with - Primed Instruments Inc

Duns Number:254491293

Device Description: Single-Use Multiple Sample Biopsy Forceps with serrated jaws and ezSlide® sheath. HIBC/UPN Single-Use Multiple Sample Biopsy Forceps with serrated jaws and ezSlide® sheath. HIBC/UPN: M453MC924A2

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More Product Details

Catalog Number

MC924A

Brand Name

CROC Multiple Sample Single-Use Biopsy Forceps

Version/Model Number

MC924A

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"

Yes

For Single-Use

Yes

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

FCL

Product Code Name

Forceps, Biopsy, Non-Electric

Device Record Status

Public Device Record Key

f8b1815d-0f07-4ce7-8bde-634cee35f269

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 26, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRIMED INSTRUMENTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40