Duns Number:093377724
Device Description: Placement of intraocular lens into the posterior chamber. Also protects iris from prolapse Placement of intraocular lens into the posterior chamber. Also protects iris from prolapse or trauma during surgical procedures.Thickness 6 mil. End radius 2.5 mm.
Catalog Number
9204
Brand Name
IOL Glide - Sheets
Version/Model Number
9204
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
KYB
Product Code Name
Lens, Guide, Intraocular
Public Device Record Key
7c3abe98-2632-42d6-8456-6aff449912d1
Public Version Date
May 13, 2020
Public Version Number
1
DI Record Publish Date
May 05, 2020
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 | 75 |