DEVICE: NSK Sterile Burs/Drills (04560264527805)

Device Identifier (DI) Information

NSK Sterile Burs/Drills
PDS-2CMS-20
In Commercial Distribution

NAKANISHI INC.
04560264527805
GS1

1
690710546 *Terms of Use
No description.
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45553 Orthopaedic bur, single-use
A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HBC MOTOR, DRILL, ELECTRIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K132264 000
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ea8967c4-80e5-4ac5-8860-e6b413687438
July 06, 2018
3
September 16, 2016
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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
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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