Revanesse Versa

GUDID 66980800001000

Revanesse Versa is manufactured by Prollenium Medical Technologies, and is a biocompatible, sterile, injectable hydrogel based on bioresorbable cross-

Prollenium Medical

Dermal tissue reconstructive material, synthetic polymer, bioabsorbable Dermal tissue reconstructive material, synthetic polymer, bioabsorbable

• Primary Device ID: 66980800001000
• NIH Device Record Key: c016f5ed-8cd0-4d49-bbdd-31f230bc882a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revanesse Versa
• Version Model Number: 40081
• Company DUNS: 247326606
• Company Name: Prollenium Medical
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	66980800001000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160042

FDA Product Code

• LMH: Implant, Dermal, For Aesthetic Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-14

Devices Manufactured by Prollenium Medical

• 10669808002394 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002400 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002417 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002424 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002431 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002448 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002455 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002462 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p