Duns Number:632899233
Device Description: The collimator is intended for a larger compression height range with breasts of larger si The collimator is intended for a larger compression height range with breasts of larger size.
Catalog Number
-
Brand Name
Collimator Cradle 512 asm
Version/Model Number
1024280
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IZW
Product Code Name
Collimator, automatic, radiographic
Public Device Record Key
e99ed7cb-189b-48be-81d7-5999e33237b5
Public Version Date
August 02, 2021
Public Version Number
4
DI Record Publish Date
September 19, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |