STOPPER
GUDID 04953170365461
OLYMPUS MEDICAL SYSTEMS CORP.
Endoscopic measuring device, viewed-object, reusable Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted| Primary Device ID | 04953170365461 |
| NIH Device Record Key | 5a26ce06-3eb2-4c39-b0d6-41b5539b05fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STOPPER |
| Version Model Number | MAJ-961 |
| Company DUNS | 711789789 |
| Company Name | OLYMPUS MEDICAL SYSTEMS CORP. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
Customer Support Contacts
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04953170365461 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K134026
FDA Product Code
| PGU | Spatial imaging for display of endoscope position |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
[04953170365461]
High-level Disinfectant;Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-08 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [STOPPER]
| 04953170365461 | MAJ-961 |
| 04953170165740 | MAJ-961 |
Trademark Results [STOPPER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STOPPER 85672716 4502402 Live/Registered |
Velmed, Inc. 2012-07-10 |
 STOPPER 77246883 3489898 Live/Registered |
VELMED, INC. 2007-08-03 |
 STOPPER 76322003 3376707 Live/Registered |
K & E Tackle, Inc. 2000-01-01 |
 STOPPER 73726832 1560550 Live/Registered |
SAFETY TECHNOLOGY INTERNATIONAL INC. 1988-05-06 |
 STOPPER 73212305 1145124 Dead/Cancelled |
ETC of Henderson, Inc. 1979-04-19 |
 STOPPER 72465405 0994548 Live/Registered |
GREAT PACIFIC IRON WORKS 1973-08-10 |
 STOPPER 72295456 0859553 Dead/Expired |
OVERALL PAINT, INC. 1968-04-11 |
 STOPPER 72255757 0825760 Dead/Expired |
ABEX CORPORATION 1966-10-05 |
 STOPPER 71503041 0426175 Dead/Expired |
AMERICAN BRAKE SHOE COMPANY 1946-05-31 |
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