DEVICE: NA (10886982237354)

Device Identifier (DI) Information

NA
511.20
In Commercial Distribution
51120
Synthes GmbH
10886982237354
GS1

1
486711679 *Terms of Use
OSCILLATING DRILL ATTACHMENT
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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?
41722 Drilling power tool attachment, oscillating
A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. The oscillating drilling movement prevents tissues and nerves from being wrapped around the drill bit during bone surgery. It may include integral design features, e.g., have an angled head or have an extended body length. The device may be of the micro or macro design. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HWE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

c349aab3-68a5-453e-8a4f-53b9f69158e7
April 25, 2022
3
December 31, 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
HIBCC H6795112003
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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
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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