Duns Number:414764719
Device Description: Coarse-tooth type, 350mm, diameter 1.8mm,10pcs/box,the minimum sales packaging is paper bo Coarse-tooth type, 350mm, diameter 1.8mm,10pcs/box,the minimum sales packaging is paper box.
Catalog Number
-
Brand Name
Jiyuan
Version/Model Number
JY-CC-350-18-S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 01, 2056
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HFB
Product Code Name
Forceps, Biopsy, Gynecological
Public Device Record Key
f417ca2f-3723-4f4c-a631-b6b0d9638a73
Public Version Date
August 10, 2022
Public Version Number
3
DI Record Publish Date
June 10, 2022
Package DI Number
16973672290042
Quantity per Package
10
Contains DI Package
06973672290045
Package Discontinue Date
March 10, 2056
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |