Duns Number:832696038
Device Description: BISHOP-HARMAN ANTERIOR CHAMBER IRRIGATING CANN, LUER LOCK HUB SILVER, FITS STD 2CC SYRINGE BISHOP-HARMAN ANTERIOR CHAMBER IRRIGATING CANN, LUER LOCK HUB SILVER, FITS STD 2CC SYRINGE OVERALL LENGTH 1-3/4" (4.4 CM)
Catalog Number
OP6791
Brand Name
V. Mueller
Version/Model Number
OP6791
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 11, 2019
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
HMX
Product Code Name
Cannula, ophthalmic
Public Device Record Key
d19a4449-70f0-4641-9248-8a4f745f030e
Public Version Date
December 11, 2019
Public Version Number
5
DI Record Publish Date
September 07, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |