Duns Number:332599307
Device Description: DC300 Diagnostic Chamber, 2,8 ccm, Lemosa Triax
Catalog Number
-
Brand Name
DC300 Diagnostic chamber
Version/Model Number
VD0702110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
064e0e93-507a-41f6-afb5-f0308dd3aa6f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
EIBAVD07021101
Quantity per Package
1
Contains DI Package
EIBAVD07021100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
chamber case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 89 |
2 | A medical device with a moderate to high risk that requires special controls. | 177 |