Duns Number:879144426
Device Description: Fiber optic light probe for intraocular illumination with tissue manipulation. 45° Retina Fiber optic light probe for intraocular illumination with tissue manipulation. 45° Retinal Knife, 20 ga, with Universal connector. Sterile, single-use.
Catalog Number
TR9806-11
Brand Name
Fiber Optic Light Guide
Version/Model Number
45°Retinal Knife, Universal
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
K875195,K875195
Product Code
FST
Product Code Name
Light, Surgical, Fiberoptic
Public Device Record Key
78ab63ee-d439-47b4-98f9-c4a03b73bda7
Public Version Date
May 07, 2019
Public Version Number
4
DI Record Publish Date
January 14, 2016
Package DI Number
10853480006065
Quantity per Package
5
Contains DI Package
00853480006068
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 |