Olympus
GUDID 04953170356001
"MAJ-675 Balloon applicator for GF-UC30P"
OLYMPUS MEDICAL SYSTEMS CORP.
Ultrasound endoscope balloon, Hevea-latex| Primary Device ID | 04953170356001 |
| NIH Device Record Key | 5676d081-d173-44dd-b2d6-7bde2dc52cdc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Olympus |
| Version Model Number | MAJ-675 |
| 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 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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| Phone | +1(800)401-1086 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04953170356001 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093395
FDA Product Code
| IYO | System, imaging, pulsed echo, ultrasonic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
[04953170356001]
Ethylene Oxide;High-level Disinfectant
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 [Olympus]
| 14953170409681 | THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S |
| 14953170409674 | THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S |
| 14953170408295 | Single Use Biopsy Forceps FB-245U |
| 14953170408288 | Single Use Biopsy Forceps FB-235U |
| 14953170408271 | Single Use Biopsy Forceps FB-225U |
| 14953170408264 | Single Use Biopsy Forceps FB-215U |
| 14953170402644 | Single Use Aspiration Needle NA-U201H |
| 14953170402620 | Single Use Aspiration Needle NA-U201H |
| 14953170402606 | Single Use Aspiration Needle NA-U201H |
| 14953170402583 | Single Use Aspiration Needle NA-U201H |
| 14953170402569 | Single Use Aspiration Needle NA-U201H |
| 14953170402545 | Single Use Aspiration Needle NA-U201H |
| 04953170402456 | OLYMPUS ENF-V4 |
| 04953170402425 | OLYMPUS ENF-VH2 |
| 14953170401074 | Single Use Surgical Scissors FS-200 |
| 14953170401050 | Single Use Loop Cutter FS-410 |
| 14953170401036 | Single Use Loop Cutter FS-410 |
| 14953170399531 | Single Use Preloaded Sphincterotome V(Distal Wireguided) |
| 14953170399524 | Single Use Preloaded Sphincterotome V(Distal Wireguided) |
| 14953170399517 | Single Use Preloaded Sphincterotome V(Distal Wireguided) |
| 14953170399500 | Single Use Preloaded Sphincterotome V(Distal Wireguided) |
| 14953170399494 | Single Use Preloaded Sphincterotome V (Distal Wireguided) |
| 14953170399487 | Single Use Preloaded Sphincterotome V (Distal Wireguided) |
| 14953170399470 | Single Use Preloaded Sphincterotome V (Distal Wireguided) |
| 14953170399463 | Single Use Preloaded Sphincterotome V (Distal Wireguided) |
| 14953170399456 | Single Use Preloaded Sphincterotome V(Distal Wireguided) |
| 14953170399449 | Single Use Preloaded Sphincterotome V(Distal Wireguided) |
| 14953170399432 | Single Use Preloaded Sphincterotome V(Distal Wireguided) |
| 14953170399425 | Single Use Preloaded Sphincterotome V(Distal Wireguided) |
| 14953170399418 | Single Use Preloaded Sphincterotome V (Distal Wireguided) |
| 14953170399401 | Single Use Preloaded Sphincterotome V (Distal Wireguided) |
| 14953170399395 | Single Use Preloaded Sphincterotome V (Distal Wireguided) |
| 14953170399388 | Single Use Preloaded Sphincterotome V (Distal Wireguided) |
| 14953170399371 | Single Use Sphincterotome V |
| 14953170399364 | Single Use Sphincterotome V |
| 14953170399357 | Single Use Sphincterotome V (Distal Wireguided) |
| 14953170399340 | Single Use Sphincterotome V(Distal Wireguided) |
| 14953170399333 | Single Use Sphincterotome V(Distal Wireguided) |
| 14953170399326 | Single Use Sphincterotome V(Distal Wireguided) |
| 14953170399319 | Single Use Sphincterotome V(Distal Wireguided) |
| 14953170399302 | Single Use Sphincterotome V(Distal Wireguided) |
| 14953170399296 | Single Use Sphincterotome V(Distal Wireguided) |
| 04953170399282 | RHINO-LARYNGO FIBERSCOPE ENF-GP2 |
| 14953170392235 | THUNDERBEAT 5mm, 20cm, Front-actuated Grip Type X |
| 14953170392228 | THUNDERBEAT 5mm, 20cm, Front-actuated Grip Type X |
| 14953170392204 | THUNDERBEAT 5mm, 35cm, Front-actuated Grip Type X |
| 14953170392198 | THUNDERBEAT 5mm, 35cm, Front-actuated Grip Type X |
| 14953170392174 | THUNDERBEAT 5mm, 45cm, Front-actuated Grip Type X |
| 14953170392167 | THUNDERBEAT 5mm, 45cm, Front-actuated Grip Type X |
| 04953170391965 | INTERFACE FOR OLYMPUS LINK DEVICE |
Trademark Results [Olympus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OLYMPUS 98323171 not registered Live/Pending |
OLYMPUS LLC 2023-12-20 |
 OLYMPUS 98183718 not registered Live/Pending |
Cable Tie Express LLC 2023-09-17 |
 OLYMPUS 98013060 not registered Live/Pending |
Olympuss Sports & Entertainment Group, LLC 2023-05-25 |
 OLYMPUS 98002376 not registered Live/Pending |
SSG International, LLC 2023-05-18 |
 OLYMPUS 97720732 not registered Live/Pending |
Valmont Industries, Inc. 2022-12-16 |
 OLYMPUS 97617017 not registered Live/Pending |
Merino, Michael 2022-10-03 |
 OLYMPUS 97493838 not registered Live/Pending |
Track Barn, LLC 2022-07-07 |
 OLYMPUS 97493792 not registered Live/Pending |
Track Barn, LLC 2022-07-07 |
 OLYMPUS 97234548 not registered Live/Pending |
Icon Technology, Inc. 2022-01-24 |
 OLYMPUS 97058514 not registered Live/Pending |
Simple Tire LLC 2021-10-04 |
 OLYMPUS 90793668 not registered Live/Pending |
Simple Tire LLC 2021-06-24 |
 OLYMPUS 90747738 not registered Live/Pending |
OLYMPUS CORPORATION 2021-06-01 |
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