Duns Number:961027315
Device Description: Impervious Surgical Gown Pack, XXL PolyReinforced
Catalog Number
9070
Brand Name
CONVERTORS
Version/Model Number
9070
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 30, 2022
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
162ac9ca-c7f1-45b3-bd92-9d25bcf600a8
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
June 22, 2016
Package DI Number
50885380034396
Quantity per Package
18
Contains DI Package
00630140026976
Package Discontinue Date
January 30, 2022
Package Status
Not 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 |