Regento Regenerative Scaffold 202937-10

GUDID 00852108006510

Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

CYTOPHIL, INC.

Bone matrix implant, synthetic

• Primary Device ID: 00852108006510
• NIH Device Record Key: 35af10dc-8b71-44c9-8fa5-bd074bb75951
• Commercial Distribution Discontinuation: 2022-07-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regento Regenerative Scaffold
• Version Model Number: 02-100-03-VTX
• Catalog Number: 202937-10
• Company DUNS: 024222105
• Company Name: CYTOPHIL, 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852108006510 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-10-30

Devices Manufactured by CYTOPHIL, INC.

• 00856509002621 - Trab-X SB Synthetic Bone Matrix: 2020-03-23 Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of
• 00852108006275 - Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules: 2020-01-27 Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting m
• 00852108006282 - Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules: 2020-01-27 Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting m
• 00856509002638 - Trab-X SB Synthetic Bone Matrix: 2020-01-27 Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of
• 00852108006411 - Callisto Granules Beta-TCP Synthetic Bone Graft: 2019-12-12 Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of
• 00852108006138 - Implant Logistics Synthetic Biphasic Dental Bone Graft Granules: 2019-12-09 Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting m
• 00852108006107 - Implant Logistics Synthetic Biphasic Dental Bone Graft Granules: 2019-11-08 Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting m
• 00852108006114 - Implant Logistics Synthetic Biphasic Dental Bone Graft Granules: 2019-11-08 Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting m