Duns Number:041546137
Device Description: Lid Plate, 20.00 mm and 24.00 mm Wide, Nonreflective surface, Length 110 mm, Stainless Ste Lid Plate, 20.00 mm and 24.00 mm Wide, Nonreflective surface, Length 110 mm, Stainless Steel
Catalog Number
16-50S
Brand Name
Rumex
Version/Model Number
16-50S
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
HOY
Product Code Name
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Public Device Record Key
c2df3a52-9ec7-4f00-bb92-2c13e8d9f2a6
Public Version Date
June 11, 2020
Public Version Number
1
DI Record Publish Date
June 03, 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 |