COOLEY COARCTATION CLAMP

GUDID B09921001850

COOLEY COARCTATION CLAMP SPOON JAW STRAIGHT SHANK

SONTEC INSTRUMENTS, INC.

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

• Primary Device ID: B09921001850
• NIH Device Record Key: 7a52a9ac-3d72-4253-a4c3-bc7df89b36ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COOLEY COARCTATION CLAMP
• Version Model Number: 2100-185
• 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
• Phone: 8008217496
• Email: INFO@SONTECINSTRUMENTS.COM

Device Dimensions

• Length: 7 Inch
• Length: 7 Inch
• Length: 7 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896010123 [Primary]
HIBCC	B09921001850 [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

[B09921001850]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09921001850]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09921001850]

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 COARCTATION CLAMP]

• 00192896091337: COOLEY COARCTATION CLAMP CURVED TIP STRAIGHT SHANK
• B09921001920: COOLEY COARCTATION CLAMP STRAIGHT JAW STRAIGHT SHANK
• B09921001850: COOLEY COARCTATION CLAMP SPOON JAW STRAIGHT SHANK
• B09921001720: COOLEY COARCTATION CLAMP STRAIGHT JAW STRAIGHT SHANK
• B09921001620: COOLEY COARCTATION CLAMP STRAIGHT JAW ANGLED SHANK
• B09921001800: COOLEY COARCTATION CLAMP CURVED JAW STRAIGHT SHANK