COOLEY DERRA CLAMP

GUDID B09921003600

COOLEY DERRA CLAMP ATRAUMATIC LARGE JAW

SONTEC INSTRUMENTS, INC.

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

• Primary Device ID: B09921003600
• NIH Device Record Key: b54aec6e-a959-4f49-93c3-1261314c55e1
• Commercial Distribution Discontinuation: 2018-06-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: COOLEY DERRA CLAMP
• Version Model Number: 2100-360
• 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: false
• 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: 8008217496
• Email: INFO@SONTECINSTRUMENTS.COM
• Phone: 8008217496
• Email: INFO@SONTECINSTRUMENTS.COM

Device Dimensions

• Length: 7.75 Inch
• Length: 7.75 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B09921003600 [Primary]

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

[B09921003600]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09921003600]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-08

On-Brand Devices [COOLEY DERRA CLAMP]

• B09921003550: COOLEY DERRA CLAMP SMALL JAW
• B09921003450: COOLEY DERRA CLAMP CURVED SMALL
• B09921003490: COOLEY DERRA CLAMP CURVED LARGE
• B09921003470: COOLEY DERRA CLAMP CURVED MEDIUM
• B09921003600: COOLEY DERRA CLAMP ATRAUMATIC LARGE JAW
• 00192896101708: COOLEY DERRA CLAMP CURVED TIP LARGE SIZE