Spatula 1SPATULA

GUDID D7981STAPULA1

Plastic, sterilization-safe mixing tool for orthodontic adhesives

RELIANCE ORTHODONTIC PRODUCTS INC

Dental material injection cannula, single-use

• Primary Device ID: D7981STAPULA1
• NIH Device Record Key: 05d610da-9501-4dcb-8bcb-adbfda2dbf0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spatula
• Version Model Number: 1SPATULA
• Catalog Number: 1SPATULA
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS 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: false
• 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: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at Ambient Conditions
• Special Storage Condition, Specify: Between 0 and 0 *Store at Ambient Conditions

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7981SPATULA0 [Primary]
HIBCC	D7981STAPULA1 [Package]; Contains: D7981SPATULA0; Package: Bag [50 Units]; In Commercial Distribution

FDA Product Code

• KXR: Applicator, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-08-21
• Device Publish Date: 2016-09-22

On-Brand Devices [Spatula]

• D7981STAPULA1: Plastic, sterilization-safe mixing tool for orthodontic adhesives
• 00840479200576: 1S