Navina Inserts 69301

GUDID 00861680000458

Starter Pack of 5 individually packaged Navina Inserts consisting of 3 regular size and 2 large size single shot Inserts

RENEW MEDICAL INC

Anal plug, single-use

• Primary Device ID: 00861680000458
• NIH Device Record Key: 649ae87f-ef05-4141-bb16-a170338c33b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navina Inserts
• Version Model Number: 69301
• Catalog Number: 69301
• Company DUNS: 967228474
• Company Name: RENEW MEDICAL 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: true
• 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: 1-888-987-2929
• Email: ricky@renew-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861680000458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122003

FDA Product Code

• PBP: Rectal Insert

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-18
• Device Publish Date: 2019-01-18

On-Brand Devices [Navina Inserts]

• 00861680000472: 30 pack carton of individually packaged Navina large size single shot Inserts
• 00861680000465: 30 pack carton of individually packaged Navina regular size single shot Inserts
• 00861680000458: Starter Pack of 5 individually packaged Navina Inserts consisting of 3 regular size and 2 large