Duns Number:085668598
Device Description: BOWMAN LACRIMAL PROBE #3-4
Catalog Number
K7-2540
Brand Name
Lacrimal Probe
Version/Model Number
K7-2540
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
90eb373d-394d-43ed-9a0d-65288dc87f8c
Public Version Date
September 22, 2020
Public Version Number
1
DI Record Publish Date
September 14, 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 | 1518 |
2 | A medical device with a moderate to high risk that requires special controls. | 26 |
U | Unclassified | 63 |