Duns Number:436857494
Device Description: LV SFE 50% FEMALE YELLOW
Catalog Number
50-434-9-A
Brand Name
NOBIL METAL SPA
Version/Model Number
LV SFE50% ATTACHMENTS
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EGG
Product Code Name
Attachment, Precision, All
Public Device Record Key
fdfe4304-76a1-4110-87bd-31ba855a9d1e
Public Version Date
August 11, 2021
Public Version Number
1
DI Record Publish Date
August 03, 2021
Package DI Number
28056039212705
Quantity per Package
6
Contains DI Package
18056039212708
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 9 |