Duns Number:438793622
Device Description: MIOT PLATE STERIBOX, EMPTY
Catalog Number
SP37900
Brand Name
MIOT PLATING SYSTEM
Version/Model Number
1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051945
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
5f159fcd-675d-43c4-bb08-cf9f6b3e5ba3
Public Version Date
September 16, 2022
Public Version Number
7
DI Record Publish Date
May 08, 2018
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 | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 6371 |