| Primary Device ID | 00821925009165 |
| NIH Device Record Key | 4b9dd663-cc56-4815-b024-0d23319466af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | R'SCOPE KIT (P) 3 ASSYS |
| Version Model Number | 714720 |
| Company DUNS | 007198742 |
| Company Name | Gyrus Acmi, 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 | true |
| Serial Number | false |
| 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 | 00821925009165 [Primary] |
| FDS | Gastroscope and accessories, flexible/rigid |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
[00821925009165]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-04 |