Duns Number:428898555
Device Description: HS NOTA 16GX200MM
Catalog Number
HS NOTA16200
Brand Name
HS NOTA
Version/Model Number
HS NOTA
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"
Yes
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
K131925,K131925
Product Code
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
7145e402-83e3-4fa4-a414-19b87d21246b
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 14, 2022
Package DI Number
38033055146969
Quantity per Package
10
Contains DI Package
08033055146968
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 | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 79 |