Duns Number:096372255
Device Description: St. Eye Speculum1/pk; 50 pks/cs
Catalog Number
32-1810
Brand Name
DeRoyal
Version/Model Number
32-1810
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
-
Product Code
HNC
Product Code Name
Specula, ophthalmic
Public Device Record Key
75af9df2-e894-4270-afcb-431c71089f35
Public Version Date
July 08, 2021
Public Version Number
1
DI Record Publish Date
June 30, 2021
Package DI Number
50749756666096
Quantity per Package
50
Contains DI Package
00749756666091
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |