DEVICE: TPS (07613327060607)
Device Identifier (DI) Information
TPS
0275601500
In Commercial Distribution
0275601500
STRYKER CORPORATION
0275601500
In Commercial Distribution
0275601500
STRYKER CORPORATION
Small-Joint Shaver Handpiece
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
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36224 | Arthroscopic shaver system, electrically-powered |
A dedicated assembly of electrically-powered devices designed for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It typically consists of a power supply/control unit with operational display and dedicated software, intended to provide optimal parameters for the procedure, and a rotatory handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotatory instruments. An irrigation system may be included. Common procedures include cartilage debridement (e.g., meniscus repair or meniscectomy) and removal of the inflamed inner lining of the joint (synovectomy). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GFA | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL |
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
a2a8ff33-bbfc-4be8-a883-94c92501b776
July 04, 2022
4
September 23, 2016
July 04, 2022
4
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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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(866)624-4422
xx@xx.xx
xx@xx.xx