Duns Number:961027315
Device Description: Urological Surgical Drape
Catalog Number
45319MNS
Brand Name
CONVERTORS
Version/Model Number
45319MNS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 07, 2021
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EYY
Product Code Name
Drape, urological, disposable
Public Device Record Key
8c98ebb4-d9b7-46f6-8a59-20aee51abd8d
Public Version Date
September 07, 2021
Public Version Number
2
DI Record Publish Date
August 21, 2018
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |