BASIS

GUDID 00889989080377

Dust Free Dental Alginate Impression Material

ORMCO CORPORATION

Alginate dental impression material

• Primary Device ID: 00889989080377
• NIH Device Record Key: bd019111-382d-4588-a47f-17ecea8b2b21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BASIS
• Version Model Number: 776-2101
• Company DUNS: 154614119
• Company Name: ORMCO CORPORATION
• Device Count: 6
• 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: 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: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com

Device Dimensions

• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram
• Weight: 2.72 Kilogram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85
• Special Storage Condition, Specify: Between 0 and 0 *Store below 85

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889989080377 [Primary]
GS1	10889989075554 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160441

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-10-11
• Device Publish Date: 2016-09-12

On-Brand Devices [BASIS]

• 00889989080407: Dust Free Dental Alginate Impression Material
• 00889989080391: Dust Free Dental Alginate Impression Material
• 00889989080384: Dust Free Dental Alginate Impression Material
• 00889989080377: Dust Free Dental Alginate Impression Material