Duns Number:961027315
Device Description: Convertors; Yellow Cover Gown with Elastic Wrists and Thumbhooks; Universal
Catalog Number
3110PG
Brand Name
CONVERTORS
Version/Model Number
3110PG
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
OEA
Product Code Name
Non-surgical isolation gown
Public Device Record Key
669c81e1-b029-426b-a0eb-ea2b44dd3025
Public Version Date
June 13, 2019
Public Version Number
1
DI Record Publish Date
June 05, 2019
Package DI Number
50885380041066
Quantity per Package
10
Contains DI Package
20885380041065
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 |