Duns Number:618214410
Device Description: Thornton Fixation Ring, swivel 13mm x 7mm C style with 15° markings, flat handle, stainle Thornton Fixation Ring, swivel 13mm x 7mm C style with 15° markings, flat handle, stainless steel
Catalog Number
E3-5631
Brand Name
Hayden Medical
Version/Model Number
E3-5631
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
279b0dbf-62b4-48eb-b28b-011b3d1954c2
Public Version Date
August 11, 2022
Public Version Number
1
DI Record Publish Date
August 03, 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 | 2893 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |