DEVICE: MicroAire® (00847399011930)
Device Identifier (DI) Information
MicroAire®
SR-275
Not in Commercial Distribution
Microaire Surgical Instruments LLC
SR-275
Not in Commercial Distribution
Microaire Surgical Instruments LLC
LARGE RECIP. SAW BLADE, 12.7mm X 78.7mm X 1mm
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? |
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45493 | Surgical saw blade, reciprocating, single-use |
A sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GES | Blade, Scalpel |
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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Width: 12.7 Millimeter |
Length: 78.7 Millimeter |
Device Size Text, specify: Cutting Thickness: 1 mm |
Device Record Status
35a7a3b1-8b7b-4aa2-b829-45284416c171
January 06, 2022
1
December 29, 2021
January 06, 2022
1
December 29, 2021
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
[?]
No Customer Contact currently defined