Duns Number:124763728
Device Description: This part contains:Five Micro small post females, (2- 0° , 1 each 5°, 11°, and 17°), Males
Catalog Number
-
Brand Name
ERA® Micro DO SP Master Kit w/ Tools SS
Version/Model Number
811403
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
EGG
Product Code Name
Attachment, Precision, All
Public Device Record Key
363bd81b-a9ca-471c-b265-bd7e9cf88f2e
Public Version Date
July 15, 2020
Public Version Number
1
DI Record Publish Date
July 07, 2020
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |