Duns Number:041810693
Device Description: Lacrimal Intubation Set, Crawford Type
Catalog Number
-
Brand Name
Lacrimal Intubation Set, Crawford Type
Version/Model Number
LIS27T
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
-
Product Code
OKS
Product Code Name
Lacrimal Stents And Intubation Sets
Public Device Record Key
17faa2bf-371a-4348-b249-d0b06b63d4ca
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
October 10, 2019
Package DI Number
20634624715275
Quantity per Package
3
Contains DI Package
10634624715278
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 168 |
U | Unclassified | 8 |