| Primary Device ID | 00836559008859 |
| NIH Device Record Key | c0ad0a1e-1c16-4a7d-aa9a-9afa8bf98ba2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PACE 101H |
| Version Model Number | PACE 101H |
| Catalog Number | PACE 101H |
| Company DUNS | 101835833 |
| Company Name | Oscor Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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(727)937-2511 |
| sales@oscor.com |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00836559008859 [Primary] |
| DTE | PULSE-GENERATOR, PACEMAKER, EXTERNAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-05 |
| Device Publish Date | 2016-09-09 |
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