DEVICE: Sterilization tray (metal, 145 x 44 x 25 mm) (07640176971235)

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Device Record History
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Device Identifier (DI) Information
Sterilization tray (metal, 145 x 44 x 25 mm)
NS123
In Commercial Distribution

Naviswiss AG
07640176971235
GS1

1
483929829 *Terms of Use
Sterilization tray (metal, 145 x 44 x 25 mm)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
62782 Optical surgical navigation device tracking system
A mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)]; it may be capable of creating digital 3-D patient models. It consists of a workstation with controls/display, position/movement tracking cameras (e.g., infrared), adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ENT, neurosurgery, CMF surgery].
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K193094 000
K223351 000
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Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
de2fb146-f53f-4cc0-83e9-d775e93353b6
April 04, 2025
2
May 16, 2024
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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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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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