COOLEY CLAMP

GUDID B09921001360

COOLEY CLAMP DOUBLE ANGLED JAW

SONTEC INSTRUMENTS, INC.

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

• Primary Device ID: B09921001360
• NIH Device Record Key: a067f576-c990-4d49-b1e0-422f4cdf761b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COOLEY CLAMP
• Version Model Number: 2100-136
• 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: 303-790-9411
• Email: info@sontecinstruments.com
• Phone: 303-790-9411
• Email: info@sontecinstruments.com
• Phone: 303-790-9411
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896010079 [Primary]
HIBCC	B09921001360 [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

[B09921001360]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09921001360]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09921001360]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-21
• Device Publish Date: 2018-08-24

On-Brand Devices [COOLEY CLAMP]

• 00192896091283: COOLEY CLAMP NEONATAL SIZE DOUBLE ANGLED TIP/SHANK B
• B09921001360: COOLEY CLAMP DOUBLE ANGLED JAW
• B09921001340: COOLEY CLAMP DOUBLE ANGLED JAW
• B09921001380: COOLEY CLAMP DOUBLE ANGLED JAW ANGLED SHANK
• B09921001320: COOLEY CLAMP DOUBLE ANGLED JAW
• B09921001300: COOLEY CLAMP DOUBLE ANGLED JAW