Duns Number:081853285
Device Description: Masket Capsulorhexis Forceps, Curved, Single Use, 10/Box
Catalog Number
SSD5 1602
Brand Name
Stephens Instruments
Version/Model Number
SSD5 1602
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
HNR
Product Code Name
Forceps, ophthalmic
Public Device Record Key
e6ca71ee-de10-4b6e-a8e6-a6c46389adfc
Public Version Date
October 01, 2020
Public Version Number
1
DI Record Publish Date
September 23, 2020
Package DI Number
00810799039644
Quantity per Package
10
Contains DI Package
00810799039651
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 |