DEVICE: HEINE OMEGA®500 LED UNPLUGGED (04053755188376)

Device Identifier (DI) Information

HEINE OMEGA®500 LED UNPLUGGED
1LS
In Commercial Distribution
C-215.40.310
Heine Optotechnik GmbH & Co. KG
04053755188376
GS1

1
315274563 *Terms of Use
No description.
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Device Characteristics

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

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

GMDN Preferred Term Name GMDN Definition
Indirect binocular ophthalmoscope, battery-powered A battery-powered, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures. It typically consists of a main light to illuminate the interior of the eyeball, a system of lenses and filters and an illuminator beam to eliminate reflexes. Also called a binocular indirect ophthalmoscope (BIO), it produces images that better overcome large refractive errors and subtle colour differences. It can be mounted on a headband or spectacle frames; the batteries may be incorporated, or the power supplied via an electrical cable from an external battery pack.
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FDA Product Code

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Product Code Product Code Name
HLJ Ophthalmoscope, Battery-Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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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

6a5fcedf-75f7-440c-bc12-f27d2a65e203
March 29, 2018
2
September 24, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
Yes
No CLOSE

Customer Contact

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+1 (603) 742-7103
service@heine-na.com
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