Duns Number:057092294
Device Description: The iTClamp® quickly controls critical bleeding by closing the skin to create a temporary,
Catalog Number
-
Brand Name
iTClamp®
Version/Model Number
9200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150813,K150813,K150813
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
165a8f97-ec2b-40dd-ace9-ddbb1bfca712
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 22, 2016
Package DI Number
10854874004032
Quantity per Package
10
Contains DI Package
00854874004035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |