DEVICE: Neoss Implant System (05060440331848)
Device Identifier (DI) Information
Neoss Implant System
41145
In Commercial Distribution
41145
Neoss AB
41145
In Commercial Distribution
41145
Neoss AB
Drill Stop 13 mm Ø2.2, 3.0, 3.4, 3.9 and 4.4 mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
65191 | Dental instrument depth limiter |
A small device in the form of a ring or cylinder intended to be placed on a surgically-invasive dental instrument or power tool endpiece (e.g., file/rasp, drill bit, reamer) to limit the depth of insertion typically into the tooth or bone; it is typically made of polymer materials (e.g., silicone). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZA | Drill, Dental, Intraoral |
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
df4ea318-7e2d-49d8-b692-cebcbb2f0b07
April 01, 2021
5
October 01, 2015
April 01, 2021
5
October 01, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
999-999-9999
contact.usa@neoss.com
contact.usa@neoss.com