Duns Number:027680821
Device Description: Intended to be used as an anti-fog agent for endoscopic camera lenses
Catalog Number
-
Brand Name
ArcRoyal Anti-Fog, Regular Solution, Sterile
Version/Model Number
AR-7304412
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
Yes
Prescription Use (Rx)
-
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
b1d2e51e-d4e3-4dc4-b30b-ba3ad8697054
Public Version Date
March 05, 2021
Public Version Number
1
DI Record Publish Date
February 25, 2021
Package DI Number
10840113230430
Quantity per Package
48
Contains DI Package
00840113230433
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |