Duns Number:447228586
Device Description: 10 CS - BONE MARROW ASPIRATIONNEEDLE, MEDIUM16 G X 30/70 MM
Catalog Number
PIP1630/70
Brand Name
PenBone
Version/Model Number
PIP1630/70
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 2021
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
235036c1-5e83-4a91-ab4e-1c32ff4535cb
Public Version Date
May 27, 2021
Public Version Number
6
DI Record Publish Date
April 13, 2017
Package DI Number
08058341212202
Quantity per Package
10
Contains DI Package
08058341212424
Package Discontinue Date
April 26, 2021
Package Status
Not 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 |