RingJect 376US1G

GUDID 08717819070286

RingJect 13/11

Ophtec B.V.

Capsular tension ring

• Primary Device ID: 08717819070286
• NIH Device Record Key: d1ed5ba4-b04e-4554-a039-318c03a04383
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RingJect
• Version Model Number: 376US1G00
• Catalog Number: 376US1G
• Company DUNS: 405048120
• Company Name: Ophtec B.V.
• 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

Customer Support Contacts

• Phone: +31505251944
• Email: info@ophtec.com

Device Dimensions

• Outer Diameter: 13 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717819070286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030023

FDA Product Code

• MRJ: Ring, Endocapsular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-09
• Device Publish Date: 2016-10-07

On-Brand Devices [RingJect]

• 08717819070286: RingJect 13/11
• 08717819070279: RingJect 12/10