Primary Device ID | 00813125015909 |
NIH Device Record Key | eda03b5e-33a1-4749-801d-704845f624a4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OtoProbe™ Short Angled Box of 6 |
Version Model Number | 14320 |
Company DUNS | 612920785 |
Company Name | IRIDEX CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | (800) 388-4747 |
techsupport@iridex.com | |
Phone | (800) 388-4747 |
techsupport@iridex.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813125015909 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-24 |
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00813125010591 - OMA (810 nm) | 2024-05-14 OMA, 810 nm, for Leica/Wild M650/M690 Operating Microscope |
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00813125016999 - SLA (577 nm) | 2024-05-14 for Zeiss 30 slit lamp or equivalent |
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