DEVICE: NA (00845384001775)

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Device Record History
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Device Identifier (DI) Information
NA
CRANI-P
Not in Commercial Distribution
CRANI-P
Synthes GmbH
00845384001775
GS1
October 01, 2025
1
486711679 *Terms of Use
6.5 cm Pediatric Craniotome Attachment. Use with XMax, eMax Systems.
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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?
42981 Trephining power tool attachment
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 function as a craniotome when an appropriate cutter is inserted. It is inserted through a pre-drilled bur hole or perforator hole and is used to cut a flap in the bone of the skull vault (calvarium). It includes a small shielding tip at the distal end to prevent the end of the cutter penetrating the dura mater membrane. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ERL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
HBC MOTOR, DRILL, ELECTRIC
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K011444 000
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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
cc706421-b65e-4f65-962a-865c340acdcd
October 01, 2025
8
February 05, 2018
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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

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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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
RA-DPYNA-anspachpowe@its.jnj.com
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