DEBAKEY NEONATAL CLAMP

GUDID B0992100580C0

DEBAKEY NEONATAL CLAMP DOUBLE ANGLED JAW/SHANK C

SONTEC INSTRUMENTS, INC.

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

• Primary Device ID: B0992100580C0
• NIH Device Record Key: e4cd75f8-e5d0-4bbc-ad9c-8a9b02eb554f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEBAKEY NEONATAL CLAMP
• Version Model Number: 2100-580C
• 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

• Length: 4.75 Inch
• Length: 4.75 Inch
• Length: 4.75 Inch
• Length: 4.75 Inch
• Length: 4.75 Inch
• Length: 4.75 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896010369 [Primary]
HIBCC	B0992100580C0 [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

[B0992100580C0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0992100580C0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0992100580C0]

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 [DEBAKEY NEONATAL CLAMP]

• 00192896090170: DEBAKEY NEONATAL CLAMP CURVED JAW/SHANK A
• 00192896090163: DEBAKEY NEONATAL CLAMP REVERSED DOUBLE ANGLED JAW/SHANK C
• B0992100579B0: DEBAKEY NEONATAL CLAMP JAW/SHANK B
• B0992100586B0: DEBAKEY NEONATAL CLAMP REVERSED DOUBLE ANGLED JAW/SHANK B
• B0992100585B0: DEBAKEY NEONATAL CLAMP LARGE DOUBLE ANGLED JAW/SHANK B
• B0992100582D0: DEBAKEY NEONATAL CLAMP LARGE DOUBLE ANGLED JAW/SHANK D
• B0992100581A0: DEBAKEY NEONATAL CLAMP SMALL DOUBLE ANGLED JAW/SHANK A
• B0992100580C0: DEBAKEY NEONATAL CLAMP DOUBLE ANGLED JAW/SHANK C
• B0992100579A0: DEBAKEY NEONATAL CLAMP JAW/SHANK A
• B0992100578C0: DEBAKEY NEONATAL CLAMP JAW/SHANK C
• B0992100577D0: DEBAKEY NEONATAL CLAMP JAW/SHANK D
• B0992605151B0: DEBAKEY NEONATAL CLAMP CURVED SHANK TITANIUM
• B0992605150D0: DEBAKEY NEONATAL CLAMP STRAIGHT TIP ANGLED SHANK TITANIUM
• B0992100592B0: DEBAKEY NEONATAL CLAMP SPOON JAW/SHANK B
• B0992100589B0: DEBAKEY NEONATAL CLAMP SMALL FULL CURVED JAW/SHANK B
• B0992100588D0: DEBAKEY NEONATAL CLAMP MEDIUM FULL CURVED JAW/SHANK D
• B0992100587D0: DEBAKEY NEONATAL CLAMP SLIGHT DOUBLE ANGLED JAW/SHANK D
• B0992100587B0: DEBAKEY NEONATAL CLAMP SLIGHT DOUBLE ANGLED JAW/SHANK B
• B0992100584B0: DEBAKEY NEONATAL CLAMP SMALL DOUBLE ANGLED JAW/SHANK B
• B0992100583D0: DEBAKEY NEONATAL CLAMP REVERSE DOUBLE ANGLED JAW/SHANK D
• B0992100583B0: DEBAKEY NEONATAL CLAMP REVERSE DOUBLE ANGLED JAW/SHANK B
• B0992100582B0: DEBAKEY NEONATAL CLAMP LARGE DOUBLE ANGLED JAW/SHANK B
• B0992100581D0: DEBAKEY NEONATAL CLAMP SMALL DOUBLE ANGLED JAW/SHANK D
• B0992100581C0: DEBAKEY NEONATAL CLAMP SMALL DOUBLE ANGLED JAW/SHANK C
• B0992100581B0: DEBAKEY NEONATAL CLAMP SMALL DOUBLE ANGLED JAW/SHANK B
• B0992100578B0: DEBAKEY NEONATAL CLAMP JAW/SHANK B
• B0992100577C0: DEBAKEY NEONATAL CLAMP JAW/SHANK C
• B0992100577B0: DEBAKEY NEONATAL CLAMP JAW/SHANK B
• B0992100576B0: DEBAKEY NEONATAL CLAMP STRAIGHT JAW/ SHANK B
• B0992100575B0: DEBAKEY NEONATAL CLAMP STRAIGHT JAW SHANK B
• B0992100592D0: DEBAKEY NEONATAL CLAMP SPOON JAW/SHANK D
• B0992100592C0: DEBAKEY NEONATAL CLAMP SPOON JAW/SHANK C
• B0992100592A0: DEBAKEY NEONATAL CLAMP SPOON JAW/SHANK A
• B0992100591D0: DEBAKEY NEONATAL CLAMP CURVED JAW/SHANK D
• B0992100591C0: DEBAKEY NEONATAL CLAMP CURVED JAW/SHANK C
• B0992100591B0: DEBAKEY NEONATAL CLAMP CURVED JAW/SHANK B
• B0992100591A0: DEBAKEY NEONATAL CLAMP CURVED JAW/SHANK A
• B0992100590D0: DEBAKEY NEONATAL CLAMP LARGE DOUBLE ANGLED JAW/SHANK D
• B0992100590C0: DEBAKEY NEONATAL CLAMP LARGE FULL CURVED JAW/SHANK C
• B0992100590B0: DEBAKEY NEONATAL CLAMP LARGE FULL CURVED JAW/SHANK B
• B0992100590A0: DEBAKEY NEONATAL CLAMP LARGE FULL CURVED JAW/SHANK A
• B0992100589D0: DEBAKEY NEONATAL CLAMP SMALL FULL CURVED JAW/SHANK D
• B0992100589C0: DEBAKEY NEONATAL CLAMP SMALL FULL CURVED JAW/SHANK C
• B0992100589A0: DEBAKEY NEONATAL CLAMP SMALL FULL CURVED JAW/SHANK A
• B0992100588C0: DEBAKEY NEONATAL CLAMP MEDIUM FULL CURVED JAW/SHANK C
• B0992100588B0: DEBAKEY NEONATAL CLAMP MEDIUM FULL CURVED JAW/SHANK B
• B0992100588A0: DEBAKEY NEONATAL CLAMP MEDIUM FULL CURVED JAW/SHANK A
• B0992100587C0: DEBAKEY NEONATAL CLAMP SLIGHT DOUBLE ANGLED JAW/SHANK C
• B0992100587A0: DEBAKEY NEONATAL CLAMP SLIGHT DOUBLE ANGLED JAW/SHANK A
• B0992100586D0: DEBAKEY NEONATAL CLAMP REVERSED DOUBLE ANGLED JAW/SHANK D