Duns Number:373139427
Device Description: Anatomy Print Model BJ
Catalog Number
ANA-MA10-00-05
Brand Name
AnatomyPrint
Version/Model Number
ANA-MA10-00-05
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 2017
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)
Yes
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
7d28f1a9-c9e0-4baf-83fe-91630d9c9e01
Public Version Date
November 27, 2019
Public Version Number
3
DI Record Publish Date
November 24, 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 |