DEVICE: 40002 PercuNav Coaxial Needle Tracker, 13G x 16 cm (00884838082984)

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Device Record History
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Device Identifier (DI) Information
40002 PercuNav Coaxial Needle Tracker, 13G x 16 cm
989605427994
In Commercial Distribution

Philips Ultrasound LLC
00884838082984
GS1

2
063377717 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
45199 Multi-purpose stereotactic surgery system
An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JAK System, x-ray, tomography, computed
IYO System, imaging, pulsed echo, ultrasonic
LLZ System, image processing, radiological
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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
706ca2e3-9ca9-4e98-9be2-6aefdecfd351
June 07, 2024
6
August 25, 2016
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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

[?]
Unit of Use DI Number: 00884838083073 CLOSE

Direct Marking (DM)

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Yes
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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