DEVICE: iTClamp® (00854874004004)
Device Identifier (DI) Information
iTClamp®
9100
In Commercial Distribution
INNOVATIVE TRAUMA CARE INC
9100
In Commercial Distribution
INNOVATIVE TRAUMA CARE INC
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.
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
38144 | Wound clip, non-biodegradable |
A device designed for the temporary, atraumatic approximation of the edges of a wound during a surgical procedure. It is typically a small, usually metallic, instrument with two blades joined at the mid-portion, or made of a single alpha-shaped part. It is typically applied manually. The device is mainly used to arrest bleeding (i.e., haemostasis); it may be used to facilitate the placing of sutures to close wounds. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXC | Clamp, Vascular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150813 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
029375e0-dd8e-4a38-a3ac-a07b22026279
July 06, 2018
3
April 18, 2016
July 06, 2018
3
April 18, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20854874004008 | 10 | 10854874004001 | In Commercial Distribution | Box | |
10854874004001 | 10 | 00854874004004 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-855-774-4528
info@itraumacare.com
info@itraumacare.com