BASIS

GUDID 00889989080391

Dust Free Dental Alginate Impression Material

ORMCO CORPORATION

Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material

• Primary Device ID: 00889989080391
• NIH Device Record Key: 69e3fa2f-7b7f-4787-9250-664e31b63d7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BASIS
• Version Model Number: 776-2103
• Company DUNS: 154614119
• Company Name: ORMCO CORPORATION
• Device Count: 25
• 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	00889989080391 [Primary]
GS1	10889989075578 [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