| Primary Device ID | 10848340006071 |
| NIH Device Record Key | e13462f8-a353-4a5d-acd1-f783c6f2b67b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Foot Switch Drape |
| Version Model Number | FS1515NS |
| Company DUNS | 130785884 |
| Company Name | ADVANCE MEDICAL DESIGNS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848340006074 [Primary] |
| GS1 | 10848340006071 [Package] Contains: 00848340006074 Package: [25 Units] In Commercial Distribution |
| JAA | System, x-ray, fluoroscopic, image-intensified |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-11 |
| Device Publish Date | 2022-11-03 |
| 10848340010481 - Mitaka Drape | 2024-04-25 Disposable Equipment Cover |
| 10848340011464 - Mitaka Spy Elite | 2024-04-25 Disposable Equipment Cover |
| 10848340015530 - Rolled Probe Cover | 2024-04-24 Disposable Equipment Cover |
| 10848340016834 - Rolled Probe Cover | 2024-04-24 Disposable Equipment Cover |
| 10848340016858 - Rolled Probe Cover | 2024-04-24 Disposable Equipment Cover |
| 10848340015547 - Rolled Probe Cover | 2024-04-23 Disposable Equipment Cover |
| 10848340012089 - Sterile Elastic Bands | 2024-04-22 Sterile Elastic Bands |
| 10848340015486 - C-Arm Pack | 2024-04-22 Disposable Equipment Cover |