DEVICE: Orascoptic - Endeavour TruColor XL Headlight System (00615375011409)
Device Identifier (DI) Information
Orascoptic - Endeavour TruColor XL Headlight System
910131-43
In Commercial Distribution
METREX RESEARCH, LLC
910131-43
In Commercial Distribution
METREX RESEARCH, LLC
NA
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? |
---|---|---|---|---|
32037 | General-purpose light source |
A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBA | LIGHT, SURGICAL HEADLIGHT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7fb1c0c6-4656-46cd-bf33-a5de1de2bd0d
December 16, 2022
1
December 08, 2022
December 16, 2022
1
December 08, 2022
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
[?]
+18003693698
CustomerCare@orascoptic.com
CustomerCare@orascoptic.com