Duns Number:300005408
Catalog Number
-
Brand Name
iCAST H&S Micro Head Double with support band 4mm
Version/Model Number
P10107-322
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
K081218,K081218
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
99c5d85b-ad5a-4d29-8f97-76e07b85d018
Public Version Date
February 14, 2022
Public Version Number
7
DI Record Publish Date
September 01, 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. | 380 |