Duns Number:001188390
Device Description: X-Ray Collimator, Huestis Part # CM-42015-001 PBL-RE/SC/IS/MSF QMI/GENERIC
Catalog Number
-
Brand Name
Huestis Medical Collimator
Version/Model Number
CM-42015-001
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
K972966
Product Code
IZX
Product Code Name
Collimator, Manual, Radiographic
Public Device Record Key
ea22a5a9-5669-41e0-bc75-7df56032aa8e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 29, 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |