DEVICE: TID - Todorich Illuminated Depressor (B384VS080016)

Device Identifier (DI) Information

TID - Todorich Illuminated Depressor
VS0800
In Commercial Distribution
VS0800
Vortex Surgical, Inc.
B384VS080016
HIBCC

1
080375891 *Terms of Use
Illuminated Depressor Cap for light pipes
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
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?
64259 Ophthalmic fibreoptic light instrument orbital-depression tip
A small transparent device intended to be placed over the traumatic tip of an ophthalmic fibreoptic light instrument to allow the instrument to be used as an illuminating orbital depressor for: 1) extra-orbital displacement of the sclera; and 2) transscleral illumination, to facilitate examination during posterior segment surgery. It is a small cap-like device made from synthetic polymer materials. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HNX Depressor, Orbital
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f5b2e8c5-6693-43f1-870b-e867cc8fea40
November 21, 2022
2
August 26, 2019
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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
No Package DIs found
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Secondary DI

[?]
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

[?]
636-778-4350
info@vortexsurgical.com
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