DEVICE: REFERENCE PLATE (04953170305672)
Device Identifier (DI) Information
REFERENCE PLATE
MAJ-1860
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1860
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1860 ScopeGuide Reference Plate
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? |
---|---|---|---|---|
64680 | Electromagnetic endoscope tracking system reference transmitter, external, body-surface |
An external component of an electromagnetic (EM) endoscope tracking system designed to emit EM pulses for spatial referencing of an appropriate EM pulse-transmitting endoscope in situ. It is intended to be attached to, or held next to, the patient; the system sensor (not included) simultaneously receives signals from both the endoscope and the reference transmitter for spatial referencing. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FDF | Colonoscope and accessories, flexible/rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K103312 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e14ee8a3-df5c-451f-abd9-77027373759a
April 22, 2024
9
September 21, 2016
April 22, 2024
9
September 21, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)401-1086
xx@xx.xx
xx@xx.xx