DEBAKEY MORRIS VASCULAR CLAMP

GUDID B09921006580

DEBAKEY MORRIS VASCULAR CLAMP ANGLED JAW CURVED SHANK

SONTEC INSTRUMENTS, INC.

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

• Primary Device ID: B09921006580
• NIH Device Record Key: 1e484c29-998d-4d3d-9405-8a149e01041e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEBAKEY MORRIS VASCULAR CLAMP
• Version Model Number: 2100-658
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896002944 [Primary]
HIBCC	B09921006580 [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

[B09921006580]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09921006580]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09921006580]

Dry Heat Sterilization;Moist Heat or Steam 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: 2018-08-24

On-Brand Devices [DEBAKEY MORRIS VASCULAR CLAMP]

• B09921006590: DEBAKEY MORRIS VASCULAR CLAMP ANGLED 2x3 JAW CURVED SHANK
• B09921006580: DEBAKEY MORRIS VASCULAR CLAMP ANGLED JAW CURVED SHANK
• B09921006570: DEBAKEY MORRIS VASCULAR CLAMP ANGLED 2X3 JAW CURVED SHANK