Duns Number:226185194
Device Description: Circumplast single use infant male circumcision device, size 13mm
Catalog Number
CIRC13MM
Brand Name
Circumplast
Version/Model Number
Circumplast 13mm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 25, 2050
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"
-
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
K151095,K151095
Product Code
HFX
Product Code Name
Clamp, Circumcision
Public Device Record Key
95cbe982-2362-4031-9aa5-107db117f9d8
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 25, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-