Duns Number:243880700
Device Description: Anti-Fog Solution Pouch with 6 g solution and adhesive sponge.
Catalog Number
G.O.L.F.F.
Brand Name
G.O.L.F.F. Glasses or Lenses Fog Free
Version/Model Number
G.O.L.F.F.
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"
Yes
For Single-Use
Yes
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
K932449,K932449
Product Code
OCT
Product Code Name
Anti Fog Solution And Accessories, Endoscopy
Public Device Record Key
07f7cb0a-189d-4870-bc31-b51f0094aaec
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 06, 2016
Package DI Number
00690521000643
Quantity per Package
20
Contains DI Package
00690521013728
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 748 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |