ASYN Strip JABB00100

GUDID 00813954026060

Moldable Bioactive Bone Graft

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 00813954026060
• NIH Device Record Key: 30be3dad-b347-4af4-901e-7f51363b4ea1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASYN Strip
• Version Model Number: JABB00100
• Catalog Number: JABB00100
• 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: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com
• Phone: 949-706-5551
• Email: info@ventrismedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• 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	00813954026060 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2023-11-08
• Device Publish Date: 2023-10-31

Devices Manufactured by COLLAGEN MATRIX, INC.

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• 00813954025261 - MatrixMem: 2024-03-20 Regenerative Collagen Dental Membrane 20mm x 30mm
• 00813954025278 - MatrixMem: 2024-03-20 Regenerative Collagen Dental Membrane 30mm x 40mm
• 00813954026046 - ASYN Puck: 2023-11-08 Moldable Bioactive Bone Graft
• 00813954026053 - ASYN Puck: 2023-11-08 Moldable Bioactive Bone Graft
• 00813954026060 - ASYN Strip: 2023-11-08Moldable Bioactive Bone Graft
• 00813954026060 - ASYN Strip: 2023-11-08 Moldable Bioactive Bone Graft