Duns Number:093377724
Device Description: Used to break-up nucleus within capsular bag during phacoemulsification. Angled 11 mm from Used to break-up nucleus within capsular bag during phacoemulsification. Angled 11 mm from tip. Tip dimensions: diameter 0.30 mm, length 1.50 mm.
Catalog Number
6811
Brand Name
Nucleus Chopper - Beckingsale
Version/Model Number
6811
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
KYB
Product Code Name
Lens, Guide, Intraocular
Public Device Record Key
551822c4-75ec-45b0-b494-63343ee9b99d
Public Version Date
May 18, 2020
Public Version Number
1
DI Record Publish Date
May 08, 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 |