Duns Number:830767898
Device Description: LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection Procedure LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection Procedures 85 inch (216 cm) (previously Hospira product)
Catalog Number
1523901
Brand Name
Irrigation Set
Version/Model Number
1523901
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
56b814f8-a063-40e1-8652-a54086f856f5
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
May 31, 2018
Package DI Number
20887787007248
Quantity per Package
10
Contains DI Package
10887787007241
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |