OrthoStore- PINA-COLADA 625-700

GUDID 00843471100080

PINA-COLADA

YOUNG INNOVATIONS HOLDINGS LLC

Alginate dental impression material

• Primary Device ID: 00843471100080
• NIH Device Record Key: 7cce2451-1baf-4b2c-a8a9-2ca7360bf7b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoStore- PINA-COLADA
• Version Model Number: 625-700
• Catalog Number: 625-700
• Company DUNS: 078739060
• Company Name: YOUNG INNOVATIONS HOLDINGS LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 2.7 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843471100080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940120

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: 2018-07-06
• Device Publish Date: 2018-02-19

Devices Manufactured by YOUNG INNOVATIONS HOLDINGS LLC

• 00843471100097 - Plak Smacker: 2020-05-06 Trufit Blue Facemask (50/bx)
• 00843471100004 - OrthoStore - BUBBLEGUM: 2018-07-06 BUBBLEGUM
• 00843471100011 - OrthoStore - COTTON CANDY: 2018-07-06 COTTON CANDY
• 00843471100028 - OrthoStore - STRAWBERRY: 2018-07-06 STRAWBERRY FLAVORING
• 00843471100035 - OrthoStore - MINT: 2018-07-06 MINT
• 00843471100042 - OrthoStore - GRAPE: 2018-07-06 GRAPE
• 00843471100059 - OrthoStore - ROOTBEER: 2018-07-06 ROOTBEER
• 00843471100066 - OrthoStore - CHERRY: 2018-07-06 CHERRY