Duns Number:217182583
Device Description: Injection Guide
Catalog Number
9-544-4
Brand Name
Duckworth & Kent
Version/Model Number
9-544-4
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 06, 2022
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
HNR
Product Code Name
Forceps, Ophthalmic
Public Device Record Key
0e385b03-a2dd-4d6a-b153-4c03ca79e290
Public Version Date
October 06, 2022
Public Version Number
3
DI Record Publish Date
August 31, 2022
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 | 505 |