Duns Number:254491293
Device Description: High capacity single-use biopsy forceps with serrated jaws, needle and ezSlide® sheath. HI High capacity single-use biopsy forceps with serrated jaws, needle and ezSlide® sheath. HIBC/UPN: M453H628S2
Catalog Number
H628S
Brand Name
CROC Series Endoscopic Device
Version/Model Number
H628S
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
84b5432e-7f69-4abf-9550-c7ed96e339de
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 23, 2017
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 |