BELLOW WITH VENTIL AND CONNECTION

GUDID B0990411020100

BELLOW BLUE WITH VENTIL AND CONNECTION M8

SONTEC INSTRUMENTS, INC.

ENT powder applicator

• Primary Device ID: B0990411020100
• NIH Device Record Key: 77d51702-07f2-458d-a2e7-a332f3256bc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BELLOW WITH VENTIL AND CONNECTION
• Version Model Number: 04-11020-10
• 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: 303-790-9411
• Email: info@sontecinstruments.com
• Phone: 303-790-9411
• Email: info@sontecinstruments.com
• Phone: 303-790-9411
• Email: info@sontecinstruments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896000094 [Primary]
HIBCC	B0990411020100 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002877

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery
• HET: Laparoscope, Gynecologic (And Accessories)

Sterilization

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

[B0990411020100]

Moist Heat or Steam Sterilization

[B0990411020100]

Moist Heat or Steam Sterilization

[B0990411020100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-25
• Device Publish Date: 2018-08-20

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