DEBAKEY COARCTATION CLAMP

GUDID B09921006300

DEBAKEY COARCTATION CLAMP STRAIGHT

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: B09921006300
• NIH Device Record Key: 8b84de18-6186-421a-b070-df5c74f0737e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEBAKEY COARCTATION CLAMP
• Version Model Number: 2100-630
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896002869 [Primary]
HIBCC	B09921006300 [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

[B09921006300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09921006300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09921006300]

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: 2018-08-23

On-Brand Devices [DEBAKEY COARCTATION CLAMP]

• B09921006340: DEBAKEY COARCTATION CLAMP STRAIGHT JAW ANGLED SHANK
• B09921006300: DEBAKEY COARCTATION CLAMP STRAIGHT
• B09921006270: DEBAKEY COARCTATION CLAMP WITH INTERLOCKING BECK SERRATION SPOON JAW
• B09921006280: DEBAKEY COARCTATION CLAMP SLIGHT SPOON JAW
• B09921006260: DEBAKEY COARCTATION CLAMP STRAIGHT JAW CURVED SHANK
• B09921006220: DEBAKEY COARCTATION CLAMP STRAIGHT
• 00192896071131: DEBAKEY COARCTATION CLAMP STRAIGHT TIP