Duns Number:809555139
Device Description: Drysdale DBL-Ended Sweeper with one facing Left and the other facing Right, Both side Angl Drysdale DBL-Ended Sweeper with one facing Left and the other facing Right, Both side Angled 12mm from Bend to Tip, Round Knurled Handle, 145mm Overall Length, Stainless Steel
Catalog Number
H673
Brand Name
Diamatrix Ltd.
Version/Model Number
H673
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HNQ
Product Code Name
Hook, Ophthalmic
Public Device Record Key
3710f5a9-0a21-4ee8-bd8b-e3aeb8bb0c19
Public Version Date
December 01, 2021
Public Version Number
1
DI Record Publish Date
November 23, 2021
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 | 475 |
U | Unclassified | 13 |