Primary Device ID | 10810068810971 |
NIH Device Record Key | 2350e74a-e3ce-4373-84df-c4ecef8bb5ea |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Monarch Endoscopy Controller |
Version Model Number | MON-000712 |
Company DUNS | 015823456 |
Company Name | AURIS HEALTH, INC. |
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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10810068810971 [Primary] |
GS1 | 20810068810978 [Package] Package: Shelf Carton [1 Units] In Commercial Distribution |
EOQ | Bronchoscope (Flexible Or Rigid) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-13 |
Device Publish Date | 2025-03-05 |
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