DEVICE: Premium Plus (D838011E2)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
18033 | Surgical mist irrigation tip |
A device that is designed to deliver a combined stream of air and mist to clear blood from a specific area of a surgical site. This device is a special perforated tip which can be affixed to an appropriate kind of tubing that delivers the rinsing fluids. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NRD | Unit, Operative Dental, Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f8d7c72f-0ae8-4a62-a71b-655c84849810
January 06, 2020
1
December 27, 2019
January 06, 2020
1
December 27, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D838011E8 | 10 | D838011E6 | In Commercial Distribution | CASE | |
D838011E6 | 6 | D838011E2 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D838011E0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined