PROFUNDA CLAMP

GUDID B0992100566D0

PROFUNDA DEBAKEY CLAMP SPOON JAW SHANK ANGLED BACKWARD

SONTEC INSTRUMENTS, INC.

Surgical soft-tissue manipulation forceps, scissors-like, reusable

• Primary Device ID: B0992100566D0
• NIH Device Record Key: 9a1b1d6d-8e91-445e-808d-3e7bff51dfea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFUNDA CLAMP
• Version Model Number: 2100-566D
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896002647 [Primary]
HIBCC	B0992100566D0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092544

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

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

[B0992100566D0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992100566D0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992100566D0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-21
• Device Publish Date: 2018-08-23

On-Brand Devices [PROFUNDA CLAMP]

• B0992100566D0: PROFUNDA DEBAKEY CLAMP SPOON JAW SHANK ANGLED BACKWARD
• B09921005660: PROFUNDA COOLEY CLAMP SPOON JAW/SHANK ANGLED BACKWARD