Duns Number:447228586
Device Description: 10 CS - DISPOSABLE CHIBA NEEDLE21G X 100MM FOR ASPIRATEDCYTO-HISTOLOGICAL BIOPSY
Catalog Number
PB2110
Brand Name
CytoCut
Version/Model Number
PB2110
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 13, 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
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
15b28e4f-9f19-4863-8bec-7d17dd7cb5cf
Public Version Date
May 27, 2021
Public Version Number
7
DI Record Publish Date
January 04, 2017
Package DI Number
08052440103294
Quantity per Package
10
Contains DI Package
08032986352059
Package Discontinue Date
May 13, 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 |