DEVICE: POINT ROBOTICS MEDTECH INC. (04719881651237)

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Device Record History
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Device Identifier (DI) Information
POINT ROBOTICS MEDTECH INC.
PSNI03-303
In Commercial Distribution

POINT ROBOTICS MEDTECH INC.
04719881651237
GS1

1
656383289 *Terms of Use
No description.
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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?
45200 Orthopaedic stereotactic surgery system
An 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 orthopaedic surgery. 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
OLO Orthopedic Stereotaxic Instrument
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K252989 000
No CLOSE

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
aaf45ef5-77bd-4d5b-a035-27345ea59c6a
April 21, 2026
1
April 13, 2026
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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)

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

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Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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