Duns Number:789337987
Device Description: LENS, OCCLUSION, MIN, CR-39
Catalog Number
6700
Brand Name
FRESNEL PRISM AND LENS
Version/Model Number
6700B
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQZ
Product Code Name
Frame, Spectacle
Public Device Record Key
e554d4c5-c420-44fb-8970-28ec326aca87
Public Version Date
August 09, 2021
Public Version Number
3
DI Record Publish Date
March 29, 2021
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 | 36 |