DEVICE: Fiber Optic Light Guide (00085348006020)

Device Identifier (DI) Information

Fiber Optic Light Guide
Standard, 20 ga, Universal
In Commercial Distribution
TR9800-11
ESCALON MEDICAL CORP.
00085348006020
GS1

1
879144426 *Terms of Use
Fiber optic light probe for intraocular illumination. Standard light guide, 20 ga, with Universal connector. Sterile, single-use
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ophthalmic fibreoptic light instrument, single-use A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It is made of high-grade stainless steel and plastic materials and has a fibreoptic bundle core that conducts the light. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FST Light, Surgical, Fiberoptic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K875195 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9cb00a3a-eb34-41c9-822f-c3c5b91df274
July 06, 2018
3
January 14, 2016
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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
10853480006027 5 00085348006020 In Commercial Distribution Box
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-486-4848
info@escalonmed.com
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