Duns Number:713565195
Device Description: Compression plate
Catalog Number
-
Brand Name
18x24 Spot compression plate
Version/Model Number
COMP PLATE SPOT 18X24 HA USA E
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MUE
Product Code Name
Full field digital,system,x-ray,mammographic
Public Device Record Key
1a1b971c-0931-478b-9c5d-de50ab669a93
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
May 01, 2021
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 | 43 |
2 | A medical device with a moderate to high risk that requires special controls. | 324 |
3 | A medical device with high risk that requires premarket approval | 1 |