Duns Number:961027315
Device Description: Convertors; Yellow Isolation Gown with Elastic Wrists and Thumbhooks; X-Large
Catalog Number
1111PG
Brand Name
CONVERTORS
Version/Model Number
1111PG
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
da50d163-fbe5-4970-9014-7fe416b47c78
Public Version Date
June 06, 2019
Public Version Number
2
DI Record Publish Date
December 06, 2018
Package DI Number
50885380041042
Quantity per Package
10
Contains DI Package
20885380041041
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 |