| Primary Device ID | 00748426130092 |
| NIH Device Record Key | 19b612d6-9def-4fd5-a607-f10cd4895e2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DePuy Synthes VELYS |
| Version Model Number | 451570018 |
| Catalog Number | 4515-70-018 |
| Company DUNS | 106908437 |
| Company Name | Microtek Medical 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00748426130092 [Primary] |
| GS1 | 30748426130093 [Package] Package: [10 Units] In Commercial Distribution |
| GS1 | 50748426130097 [Package] Contains: 30748426130093 Package: [2 Units] In Commercial Distribution |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00748426130092]
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| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-17 |
| Device Publish Date | 2023-03-09 |
| 00748426124909 | VELYS Satellite Station Drape_EO_20CS |
| 00748426124886 | VELYS Device Sterile Drape_EO_20CS |
| 50748426130110 | VELYS™ Satellite Station Drape |
| 00748426130092 | VELYS Device Sterile Drape |