Duns Number:041546137
Device Description: "Flynn Scleral Depressor, For Depressing Pediatric Sclera, Length 90 mm, Round Titanium H "Flynn Scleral Depressor, For Depressing Pediatric Sclera, Length 90 mm, Round Titanium Handle"
Catalog Number
16-115
Brand Name
Rumex
Version/Model Number
16-115
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HNX
Product Code Name
Depressor, Orbital
Public Device Record Key
eb64d42e-5806-4c68-b69d-a9af1816d32c
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
June 22, 2020
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 | 834 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |