Duns Number:007941230
Device Description: Short Examination Elastic Waist Band Large Sms Blue Disposable Not Made With Natural Rubbe
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
181102
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)
-
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
aaa1cede-f030-4e85-88a1-dcc36fb5789a
Public Version Date
October 27, 2020
Public Version Number
1
DI Record Publish Date
October 19, 2020
Package DI Number
50885632103993
Quantity per Package
4
Contains DI Package
30885632103999
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |