GROOVED DIRECTOR 197-693

GUDID 00192896076679

GROOVED DIRECTOR TONGUE TIE STAINLESS STEEL

SONTEC INSTRUMENTS, INC.

Gastro-urological probe Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director Gastro-urological director

• Primary Device ID: 00192896076679
• NIH Device Record Key: f607fa0d-aff0-4b76-9f6c-0a45bbbb97e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GROOVED DIRECTOR
• Version Model Number: 197-693
• Catalog Number: 197-693
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896076679 [Primary]

FDA Product Code

• FGM: Probe And Director, Gastro-Urology
• HXP: INSTRUMENT, BENDING OR CONTOURING

Sterilization

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

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896076679]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-03-11
• Device Publish Date: 2018-09-20

On-Brand Devices [GROOVED DIRECTOR]

• 00192896076709: GROOVED DIRECTOR TONGUE TIE PROBE TIP STAINLESS STEEL
• 00192896076693: GROOVED DIRECTOR TONGUE TIE PROBE TIP STAINLESS STEEL
• 00192896076686: GROOVED DIRECTOR TONGUE TIE PROBE TIP STAINLESS STEEL
• 00192896076679: GROOVED DIRECTOR TONGUE TIE STAINLESS STEEL
• 00192896076662: GROOVED DIRECTOR TONGUE TIE STAINLESS STEEL
• 00192896115217: Grooved Director With Tongue Tie Stainless Steel
• 00192896117488: Grooved Director With Tongue Tie Stainless Steel