Depth Gauges GW-MOL-DEPG

GUDID 00858395006028

Used to gauge the depth of the pulp chamber. Depth Gauges help determine the proper Sealing Cap needed to prepare the Molar Procedure Instrument for procedure.

SONENDO, INC.

Dental delivery system instrument unit, electric

• Primary Device ID: 00858395006028
• NIH Device Record Key: 6595a36d-f606-4071-a575-b06cf0887bc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Depth Gauges
• Version Model Number: FG-001-00002
• Catalog Number: GW-MOL-DEPG
• Company DUNS: 828894373
• Company Name: SONENDO, INC.
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 8447663636
• Email: info@sonendo.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858395006028 [Primary]
GS1	00858395006172 [Unit of Use]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

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