CROC Series Endoscopic Device - Single-use wide angled retrieval device with rat - Primed Instruments Inc

Duns Number:254491293

Device Description: Single-use wide angled retrieval device with rat tooth/alligator hybrid jaws and ezSlide® Single-use wide angled retrieval device with rat tooth/alligator hybrid jaws and ezSlide® sheath. HIBC/UPN: M453RC9242

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More Product Details

Catalog Number

RC924

Brand Name

CROC Series Endoscopic Device

Version/Model Number

RC924

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

761e5a33-b2a6-4ea9-95fe-6acb99928e34

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

October 23, 2017

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