Duns Number:763408366
Device Description: EXTERNAL OCULID PINK® - 1,4 g
Catalog Number
-
Brand Name
EXTERNAL OCULID PINK® - 1,4 g
Version/Model Number
S3.60141
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
MML
Product Code Name
Weights, Eyelid, External
Public Device Record Key
3ac65702-da1a-4f1a-87c2-9d71167c4e40
Public Version Date
March 16, 2022
Public Version Number
1
DI Record Publish Date
March 08, 2022
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 | 82 |
2 | A medical device with a moderate to high risk that requires special controls. | 291 |
U | Unclassified | 60 |