| Primary Device ID | 04953170248702 |
| NIH Device Record Key | aedbafbf-02fb-44ec-b4e4-90f9ce738882 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GUARD RAIL |
| Version Model Number | MAJ-1772 |
| Company DUNS | 711789789 |
| Company Name | OLYMPUS MEDICAL SYSTEMS CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| 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 |
| 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 |
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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 |
| 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 |
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| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04953170248702 [Primary] |
| FEM | ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2018-09-21 |
| 04953170421815 - Reusable Cordless Transducer | 2025-12-12 |
| 14953170439992 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm | 2025-12-12 |
| 14953170440004 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm | 2025-12-12 |
| 14953170440011 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm | 2025-12-12 |
| 14953170440028 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm | 2025-12-12 |
| 04953170442353 - ULTRASONIC BIPOLAR GENERATOR | 2025-12-12 "This product is Version 2. A Version 1 product with the same name exists." |
| 04953170442445 - Update Tool for USG-410 | 2025-12-12 |
| 14953170459204 - Single-use Fine Needle Biopsy (FNB) Device NA-U210H | 2025-12-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GUARD RAIL 81009903 1009903 Dead/Cancelled |
Uniroyal, Inc. 0000-00-00 |