Duns Number:447228586
Device Description: DISPOSABLE BONE MARROW BIOPSY NEEDLE WITH INTERNAL TRAP SYSTEM, SAFETY, WIRE 13G x 100 mm
Catalog Number
PS1310
Brand Name
PressTo
Version/Model Number
PS1310
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
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
DWO
Product Code Name
Needle, Biopsy, Cardiovascular
Public Device Record Key
17437fe7-ae1d-4dd5-96a0-932a280022ca
Public Version Date
May 27, 2021
Public Version Number
2
DI Record Publish Date
May 17, 2021
Package DI Number
18056138586434
Quantity per Package
10
Contains DI Package
08056138586437
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 | 228 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 138 |