Duns Number:373139427
Device Description: Anatomical Model, Orbit, Clear
Catalog Number
SD900.203
Brand Name
ProPlan CMF
Version/Model Number
SD900.203
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
Yes
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
HWT
Product Code Name
Template
Public Device Record Key
731c39fb-e3bd-4e73-a8a4-00e2e00f6cc2
Public Version Date
November 27, 2019
Public Version Number
3
DI Record Publish Date
September 13, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 91 |
2 | A medical device with a moderate to high risk that requires special controls. | 296 |