DEVICE: Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm) (08717872021942)

Device Identifier (DI) Information

Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm)
3269.MBD27
Not in Commercial Distribution
3269.MBD27
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
08717872021942
GS1
July 04, 2017
6
407522184 *Terms of Use
No description.
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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?
45193 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 has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MPA Endoilluminator
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062895 000
No 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

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Size Type Text
No Device Sizes
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Device Record Status

0e5a4d89-6eed-4f06-b5e0-ae0747b7f1f9
October 05, 2022
6
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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: 18717872021949 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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