Duns Number:373139427
Device Description: Mimics Plugin Segment Thin Bone
Catalog Number
Segment Thin Bone
Brand Name
Mimics Plugin
Version/Model Number
Segment Thin Bone
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
K183105
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
8b8c41aa-483c-43e9-9486-f54eca40336f
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
May 18, 2021
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 |