Duns Number:790888833
Device Description: Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin
Catalog Number
-
Brand Name
MAX-100
Version/Model Number
MAX-100 Syringe
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
Yes
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
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
97c3ccf5-3736-405c-8394-eb6c89d5a074
Public Version Date
September 16, 2020
Public Version Number
2
DI Record Publish Date
August 21, 2018
Package DI Number
B641MAX1004
Quantity per Package
250
Contains DI Package
B641MAX1002
Package Discontinue Date
September 15, 2020
Package Status
Not in Commercial Distribution
Package Type
Corrugated Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |