iTClamp®

Basic Information

• Brand Name: iTClamp®
• Primary DI: 00854874004004
• Version / Model: 9100
• Company Name: INNOVATIVE TRAUMA CARE INC
• Labeler DUNS: 057092294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-18
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 029375e0-dd8e-4a38-a3ac-a07b22026279

Device Description

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20854874004008	GS1	Box	10	In Commercial Distribution
Package	10854874004001	GS1	Carton	10	In Commercial Distribution
Primary	00854874004004	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150813	000