Duns Number:042823948
Device Description: Offset P.C.B. Paracervical Block Needle
Catalog Number
J-PCB-220902
Brand Name
Cook
Version/Model Number
G16554
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
FBK
Product Code Name
endoscopic injection needle, gastroenterology-urology
Public Device Record Key
63c57b23-a35c-421f-bce8-13c87e9bd8fb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 09, 2016
Package DI Number
10827002165547
Quantity per Package
5
Contains DI Package
00827002165540
Package Discontinue Date
-
Package Status
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 | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |