Duns Number:447228586
Device Description: 10 CS-DISPOSABLE BONE BIOPSY NEEDLEFOR ILIAC CREST MARROW ASPIRATION,"T" HANDLE 16G x 35/1 10 CS-DISPOSABLE BONE BIOPSY NEEDLEFOR ILIAC CREST MARROW ASPIRATION,"T" HANDLE 16G x 35/100 mm
Catalog Number
PIL1635/100
Brand Name
Illy
Version/Model Number
PIL1635/100
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
ca319a3a-1c5b-4222-bce6-4ba13e7b4f04
Public Version Date
May 27, 2021
Public Version Number
6
DI Record Publish Date
January 05, 2017
Package DI Number
08052440100972
Quantity per Package
10
Contains DI Package
08032986359003
Package Discontinue Date
May 14, 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 |