RingJect 375US1G

GUDID 08717819070279

RingJect 12/10

Ophtec B.V.

Capsular tension ring
Primary Device ID08717819070279
NIH Device Record Key38fbbd73-9bfb-43f8-ab71-75cd23241ac5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRingJect
Version Model Number375US1G00
Catalog Number375US1G
Company DUNS405048120
Company NameOphtec B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31505251944
Emailinfo@ophtec.com

Device Dimensions

Outer Diameter12 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108717819070279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRJRing, Endocapsular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-09
Device Publish Date2016-10-07

On-Brand Devices [RingJect]

08717819070286RingJect 13/11
08717819070279RingJect 12/10

Trademark Results [RingJect]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RINGJECT
RINGJECT
79264307 not registered Live/Pending
OPHTEC B.V.
2019-05-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.