Duns Number:006999858
Device Description: Mammography Cape. Front Closure, 3/4 Length Sleeves Set In, White Bias Binding, White Twil Mammography Cape. Front Closure, 3/4 Length Sleeves Set In, White Bias Binding, White Twill Ties at Waist on Inside and Outside, OSFA
Catalog Number
74405480
Brand Name
MAMMOGRAM CAPE
Version/Model Number
74405480
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"
-
For Single-Use
-
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
FME
Product Code Name
Gown, Examination
Public Device Record Key
8e89d030-f9b5-4787-9539-a3e8bbc93b83
Public Version Date
April 13, 2020
Public Version Number
1
DI Record Publish Date
April 03, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |