OrthoStore - BUBBLEGUM 625-100

GUDID 00843471100004

BUBBLEGUM

YOUNG INNOVATIONS HOLDINGS LLC

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: 00843471100004
• NIH Device Record Key: e77a41e2-1043-4391-b8d0-a9485d70181a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoStore - BUBBLEGUM
• Version Model Number: 625-100
• Catalog Number: 625-100
• 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	00843471100004 [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
• 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