MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER 20918-08-303

GUDID 00192896007963

MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER WITH HEGAR RATCHET CURVED TIP WIDE JAW

SONTEC INSTRUMENTS, INC.

Needle holder, reusable

• Primary Device ID: 00192896007963
• NIH Device Record Key: a7986ba9-bcd8-44e7-a126-6ba23408d3af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER
• Version Model Number: 20918-08-303
• Catalog Number: 20918-08-303
• 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
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• 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: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch
• Length: 11.75 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896007963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002877

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896007963]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-17
• Device Publish Date: 2018-08-15

On-Brand Devices [MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER]

• 00192896007963: MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER WITH HEGAR RATCHET CURVED TIP WIDE JAW
• 00192896007956: MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER WITH HEGAR RATCHET CURVED TIP WIDE JAW