DEVICE: Surgical Direct (B382SD85331170)
Device Identifier (DI) Information
Surgical Direct
SD8533117
In Commercial Distribution
SD8533117
Surgical Direct, Inc.
SD8533117
In Commercial Distribution
SD8533117
Surgical Direct, Inc.
3.8mm 10` Autoclavable Fiber Optic Light Cable, Yellow, Light Source Type: Wolf, Dyonics, and Stryker X8000, and L9000..Scope Type: Storz Large Thread, Screw On
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? |
---|---|---|---|---|
35507 | Fibreoptic light cable |
A flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FFS | Image, Illumination, Fiberoptic, For Endoscope |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K021931 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 10 Feet |
Outer Diameter: 3.8 Millimeter |
Device Record Status
f7c8fbdf-2c79-442b-bca5-8cde116a143e
April 17, 2024
2
April 25, 2020
April 17, 2024
2
April 25, 2020
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 |
---|---|
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) 519-3293
info@surgicaldirect.com
info@surgicaldirect.com