Duns Number:057092294
Device Description: The iTClamp® quickly controls critical bleeding by closing the skin to create a temporary, The iTClamp® quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp® is a self-locking trauma clamp with needles that penetrate the skin to evert the skin edges between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal. The iTClamp Model 9200 is a non-sterile training product, not for clinical use.
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 |