Duns Number:196603781
Device Description: 23G ST ASP L PROBE 5/BOX
Catalog Number
BL5293ASP
Brand Name
Bausch + Lomb
Version/Model Number
BL5293ASP
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
K061024,K061024
Product Code
HQE
Product Code Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Public Device Record Key
b007e7f8-9239-4b33-bbd1-d4627bfb15f5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 | 77 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 134 |
| 3 | A medical device with high risk that requires premarket approval | 3348 |
| U | Unclassified | 1 |