| Primary Device ID | 14953170420297 |
| NIH Device Record Key | bca25918-260b-4da1-9122-557dc7ba4bd3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Use Mechanical Lithotriptor BML-610A |
| Version Model Number | BML-610A |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 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 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04953170420290 [Primary] |
| GS1 | 14953170420297 [Package] Contains: 04953170420290 Package: [1 Units] In Commercial Distribution |
| LQC | Lithotriptor, Biliary Mechanical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-27 |
| Device Publish Date | 2021-12-17 |