Duns Number:187129135
Device Description: Kit Contains:C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BXCTF12, 5x100 Kii Fios ZTHR DP 10/BXCT Kit Contains:C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BXCTF12, 5x100 Kii Fios ZTHR DP 10/BXCTF73, 12x100 Kii Fios ZTHR 6/BXCA090, DIRECT DRIVE LCA 3/BXCD001, 10mm RETRIEVAL SYSTEM, 10/BXCB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BXC6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX
Catalog Number
-
Brand Name
CHOLE KIT 5
Version/Model Number
GK318
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"
Yes
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
FHF
Product Code Name
System, Evacuator, Fluid
Public Device Record Key
1397dc05-0778-4078-b716-1a20be35ddfc
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
October 09, 2015
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 | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |