Duns Number:080935429
Device Description: Bone Marrow Biopsy and Aspiration Tray with Safety Components,16 G I-Type Sternal-Iliac Ne Bone Marrow Biopsy and Aspiration Tray with Safety Components,16 G I-Type Sternal-Iliac Needle and 11 G Snarecoil Bone Marrow Needle
Catalog Number
SC4511
Brand Name
Monoject
Version/Model Number
SC4511
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAA
Product Code Name
NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
Public Device Record Key
d7240795-668b-4668-8977-d53b232078a9
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 30, 2018
Package DI Number
20884521020440
Quantity per Package
10
Contains DI Package
10884521020443
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |