iTClamp®

GUDID 10854874004032

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.

INNOVATIVE TRAUMA CARE INC

Wound clip, non-biodegradable

• Primary Device ID: 10854874004032
• NIH Device Record Key: 165a8f97-ec2b-40dd-ace9-ddbb1bfca712
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTClamp®
• Version Model Number: 9200
• Company DUNS: 057092294
• Company Name: INNOVATIVE TRAUMA CARE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-774-4528
• Email: info@itraumacare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854874004035 [Primary]
GS1	10854874004032 [Package]; Contains: 00854874004035; Package: Carton [10 Units]; In Commercial Distribution
GS1	20854874004039 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150813

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-22

On-Brand Devices [iTClamp®]

• 10854874004032: The iTClamp® quickly controls critical bleeding by closing the skin to create a temporary, cont
• 20854874004015: The iTClamp® quickly controls critical bleeding by closing the skin to create a temporary, cont
• 20854874004008: The iTClamp® quickly controls critical bleeding by closing the skin to create a temporary, cont