Duns Number:254491293
Device Description: Single-Use Multiple Sample Biopsy Forceps and ezSlide® sheath. HIBC/UPN: M453MC924R1
Catalog Number
MC924R
Brand Name
CROC Multiple Sample Single-Use Biopsy Forceps
Version/Model Number
MC924R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
FCL
Product Code Name
Forceps, Biopsy, Non-Electric
Public Device Record Key
cf5faa86-6076-4c87-a633-da1fe0f2d0dc
Public Version Date
December 24, 2018
Public Version Number
1
DI Record Publish Date
November 22, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 40 |