DEVICE: POWERTEK II PLUS SHAVER (00880304460492)
Device Identifier (DI) Information
POWERTEK II PLUS SHAVER
906063
In Commercial Distribution
906063
Biomet Orthopedics, LLC
906063
In Commercial Distribution
906063
Biomet Orthopedics, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
53617 | Arthroscopic shaver system handpiece, electrically-powered |
A handle with attached cutting blade that is a component of an electrically-powered arthroscopic shaver system designed for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is typically connected to and regulated by a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and is used in combination with appropriate endoscopic devices. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRX | Arthroscope |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K020761 | 000 |
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
04113642-c0f6-4b16-8b5c-5b178c7d031a
May 30, 2025
5
July 28, 2017
May 30, 2025
5
July 28, 2017
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
[?]
+1(800)348-9500
customerservice@zimmerbiomet.com
customerservice@zimmerbiomet.com