Duns Number:081853285
Device Description: Shocket Scleral Depressor, Single Use, 10/Box
Catalog Number
SSD4 1231
Brand Name
Stephens Instruments
Version/Model Number
SSD4 1231
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
-
Product Code
HNX
Product Code Name
Depressor, orbital
Public Device Record Key
0bfe9d33-b4a0-4818-a70a-d16206f50dae
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2020
Package DI Number
00810799039408
Quantity per Package
10
Contains DI Package
00810799039415
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 995 |
U | Unclassified | 24 |