SynOss Plug SMCP1020

GUDID 10813954026791

Bone Graft Composite

COLLAGEN MATRIX, INC.

Dental bone matrix implant, synthetic

• Primary Device ID: 10813954026791
• NIH Device Record Key: f578a1dc-1ca8-4b68-b5d1-ca331d03085f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynOss Plug
• Version Model Number: SMCP1020
• Catalog Number: SMCP1020
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, INC.
• 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: 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: 201-405-1477
• Email: contact@regenity.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954026794 [Primary]
GS1	10813954026791 [Package]; Contains: 00813954026794; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• NPM: Bone Grafting Material, Animal Source

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-15
• Device Publish Date: 2025-09-05

On-Brand Devices [SynOss Plug]

• 10813954026791: Bone Graft Composite
• 10813954026784: Bone Graft Composite