Duns Number:961027315
Device Description: Basic Pack with Impervious Reinforced Gowns
Catalog Number
9114
Brand Name
CONVERTORS
Version/Model Number
9114
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRO
Product Code Name
General surgery tray (kit)
Public Device Record Key
6b445d3a-9c84-4a55-b697-c5d3a1ba6efc
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
July 13, 2016
Package DI Number
50885380010048
Quantity per Package
5
Contains DI Package
10885380010040
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |