Duns Number:447228586
Device Description: 10 CS-DISPOSABLE BONE BIOPSY NEEDLEFOR ILIAC CREST MARROW ASPIRATION,"T" HANDLE 14G x 35/1 10 CS-DISPOSABLE BONE BIOPSY NEEDLEFOR ILIAC CREST MARROW ASPIRATION,"T" HANDLE 14G x 35/100 mm
Catalog Number
PIL1435/100
Brand Name
Illy
Version/Model Number
PIL1435/100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 14, 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
75489aae-f46e-4c67-9434-c8ed7a6737ee
Public Version Date
May 27, 2021
Public Version Number
6
DI Record Publish Date
April 13, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |