Duns Number:832696038
Device Description: ILLINOIS NEEDLE BONE MARROW 15G ADJUSTABLE LEN
Catalog Number
DIN1515X
Brand Name
Jamshidi
Version/Model Number
DIN1515X
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
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
2cf617fa-1668-41b9-b0fe-26526315c70d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2017
Package DI Number
50885403087040
Quantity per Package
10
Contains DI Package
10885403087042
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 | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |