Primary Device ID | 00860624000400 |
NIH Device Record Key | ba267bdd-0961-4f12-8b9c-bf0d9725f042 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Image Control Box |
Version Model Number | Image Control Box |
Catalog Number | Image Control Box |
Company DUNS | 080909607 |
Company Name | REBOUND THERAPEUTICS 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 | 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 |
Phone | +1(800)654-2873 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 00860624000400 [Primary] |
GWG | Endoscope, Neurological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-02-22 |
Device Publish Date | 2019-01-22 |
00850002332049 - AURORA® | 2022-12-07 Surgiscope® System Power Cable |
00850002332247 - Aurora Surgiscope System | 2021-05-26 The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgisco |
00850002332254 - Aurora Surgiscope System | 2021-05-26 The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgisco |
00850002332261 - Aurora Surgiscope System | 2021-05-26 The Image Control Box (ICB) provides power to the AURORA Surgiscope, transfers the video to a Display Monitor, and allows the us |
00850002332209 - AURORA Evacuator +Coag | 2021-01-20 The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that |
00850002332216 - AURORA Evacuator +Coag | 2021-01-20 The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that |
00850002332223 - AURORA Evacuator +Coag | 2021-01-20 The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that |
00850002332148 - AURORA Evacuator | 2020-02-14 The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remov |