Duns Number:314594680
Device Description: This database entry covers UDI for SW Versions 2.0 and higher (Glaucoma Workplace): (01)04 This database entry covers UDI for SW Versions 2.0 and higher (Glaucoma Workplace): (01)04049471070101(10)310 -> Version 3.1, (01)04049471070101(10)311 -> Version 3.1.1, (01)04049471070101(10)350 -> Version 3.5
Catalog Number
-
Brand Name
FORUM Glaucoma Workplace
Version/Model Number
2.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NFJ
Product Code Name
System, Image Management, Ophthalmic
Public Device Record Key
c200619e-c78a-4b14-8e45-0883e4e89505
Public Version Date
October 03, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| 3 | A medical device with high risk that requires premarket approval | 1 |