Duns Number:879144426
Device Description: Hardten Iris Retractor Fiber optic light probe with a hooked tip for manipulation and retr Hardten Iris Retractor Fiber optic light probe with a hooked tip for manipulation and retraction of the iris for optimal visualization of anterior vitreous. 20 ga, with Universal connector. Sterile, single-use.
Catalog Number
TR9809-11
Brand Name
Fiber Optic Light Guide
Version/Model Number
Iris Retractor, 20 ga
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HNI
Product Code Name
Retractor, Ophthalmic
Public Device Record Key
64a51306-669d-49f8-b082-26a68839968f
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
January 14, 2016
Package DI Number
10853480006126
Quantity per Package
5
Contains DI Package
00853480006129
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |