DEVICE: Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer (M678SLSS0)

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Device Record History
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Device Identifier (DI) Information
Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer
ROVER SLS
In Commercial Distribution
ROVER SLS-S
SUNOPTIC TECHNOLOGIES LLC
M678SLSS0
HIBCC

1
094586898 *Terms of Use
Battery powered light source for illumination of a surgical field.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
65349 Open surgical site internal light
An electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FCW Light Source, Fiberoptic, Routine
FTD Lamp, Surgical
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Device should be stored in cool dry location
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ddf1c94f-b6f6-41c6-a38d-f8e37f7feb81
March 20, 2025
4
March 01, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
M678SLSS1 5 M678SLSS0 In Commercial Distribution
M678SLSS3 20 M678SLSS0 In Commercial Distribution
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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