DEVICE: Reprocessed Micro Choice Oscillating Blade, Fine, 10 x 35 x 0.4mm (B39050231691)

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Device Record History
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Device Identifier (DI) Information
Reprocessed Micro Choice Oscillating Blade, Fine, 10 x 35 x 0.4mm
5023-169
In Commercial Distribution

SURETEK MEDICAL
B39050231691
HIBCC

1
785616934 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
Yes
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GMDN

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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?
52749 Surgical power tool system handpiece, sawing, line-powered
A hand-held, line-powered device (which may in addition include a rechargeable battery) that consists of a motorized saw handpiece intended to provide sagittal, oscillating, or reciprocating movement for attachable serrated blades designed to cut through hard/tough tissue during surgery. The device may be of the micro or macro design. It is powered from a control unit that supplies mains, stepped-down, low-voltage electricity (e.g., 24 volt) directly via an electrical connection cable. It is typically operated with a hand- or foot-switch. This is a reusable device.
Obsolete false
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FDA Product Code

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Product Code Product Code Name
GFA Blade, Saw, General & Plastic Surgery, Surgical
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
da570ac7-b18f-492a-a224-c27ee7d7d76e
May 03, 2021
1
April 23, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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