| Primary Device ID | 20842430101773 |
| NIH Device Record Key | 78903b05-4a51-4541-a3d6-8f384d909725 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pkit, STS Trios, LPV, SG, Arm Pad |
| Version Model Number | 5808PV-1 |
| Catalog Number | 5808PV |
| Company DUNS | 084527241 |
| Company Name | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
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| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842430101779 [Primary] |
| GS1 | 10842430101776 [Package] Contains: 00842430101779 Package: case [6 Units] In Commercial Distribution |
| GS1 | 20842430101773 [Package] Contains: 00842430101779 Package: case [3 Units] In Commercial Distribution |
| KME | Bedding, Disposable, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-05-25 |
| Device Publish Date | 2018-04-24 |