Duns Number:832696038
Device Description: QUICKER LACRIMAL INTUBATION PROBE, ONE END, JONES TAPER POINT, OTHER END, REGULAR BOWMAN P QUICKER LACRIMAL INTUBATION PROBE, ONE END, JONES TAPER POINT, OTHER END, REGULAR BOWMAN POINT, MALL, SIZE 3
Catalog Number
OP0918-705
Brand Name
V. Mueller
Version/Model Number
OP0918-705
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
HNL
Product Code Name
Probe, lachrymal
Public Device Record Key
cc038778-3fad-44d6-8187-bd5973c23110
Public Version Date
October 08, 2018
Public Version Number
1
DI Record Publish Date
September 05, 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 |