Duns Number:659959431
Device Description: Sterile Nipple Shield
Catalog Number
-
Brand Name
LANSINOH
Version/Model Number
70195
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HGY
Product Code Name
Pump, Breast, Non-Powered
Public Device Record Key
3f54307b-27ea-493d-b350-0ea9eace67cf
Public Version Date
April 19, 2022
Public Version Number
1
DI Record Publish Date
April 11, 2022
Package DI Number
10044677701959
Quantity per Package
20
Contains DI Package
00044677701952
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |