Duns Number:006999858
Device Description: Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, single metal snap at front opening, 3XL
Catalog Number
74347789
Brand Name
MAMMOGRAPHY GOWN
Version/Model Number
74347789
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
36cc465d-ca83-452b-b920-3f00c1b2b03a
Public Version Date
June 04, 2018
Public Version Number
1
DI Record Publish Date
May 03, 2018
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 |