Primary Device ID | 04059237000617 |
NIH Device Record Key | 0336ef6e-675a-4d95-9d62-3f5275046101 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ANTERION |
Version Model Number | 88036 |
Company DUNS | 329833875 |
Company Name | Heidelberg Engineering GmbH |
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 | true |
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 | 04059237000617 [Primary] |
OBO | Tomography, Optical Coherence |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-01-11 |
Device Publish Date | 2022-01-03 |
04059237000617 | 88036 |
04059237000754 | Software with HEYEX 2 V1.2.3 |
04059237000877 | 88036 |
04059237000945 | Software V.1.2.4 US |
04059237000938 | 88036 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ANTERION 79222790 5624707 Live/Registered |
Heidelberg Engineering GmbH 2017-10-24 |