DuraTip® DURA30-US

GUDID 00810000522927

30K DuraTip® Universal Slim Insert

PARKELL, INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 00810000522927
• NIH Device Record Key: 11c6aa6f-34a2-407f-87e8-c5d3bf238feb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraTip®
• Version Model Number: DURA30-US
• Catalog Number: DURA30-US
• Company DUNS: 009900424
• Company Name: PARKELL, 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: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000522927 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

[00810000522927]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-30
• Device Publish Date: 2023-10-20

On-Brand Devices [DuraTip®]

• 00810000522927: 30K DuraTip® Universal Slim Insert
• 00810000522903: 30K DuraTip® Perio Slim Insert