Duns Number:763408366
Device Description: An implantable short tube intended to provide a bypass route for tear drainage from the co
Catalog Number
-
Brand Name
RITLENG+
Version/Model Number
S1.1455
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
bcc996da-0e9e-4d55-a88c-23fad921ef26
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 30, 2021
Package DI Number
33760087127264
Quantity per Package
3
Contains DI Package
03760087127263
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 291 |
| U | Unclassified | 60 |