| Primary Device ID | 10848340005449 |
| NIH Device Record Key | 47657330-c8af-49a5-89ba-a19cd1773e36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Equipment Cover |
| Version Model Number | 08-CC184 |
| 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 | false |
| Expiration Date | true |
| 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 | 00848340005442 [Primary] |
| GS1 | 10848340005449 [Package] Contains: 00848340005442 Package: [6 Units] In Commercial Distribution |
| JAA | System, x-ray, fluoroscopic, image-intensified |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
[10848340005449]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-16 |
| Device Publish Date | 2021-12-08 |
| 10848340005449 | Synthes Fluid Warmer Drape |
| 10848340014878 | Light Handle Cover |
| 10848340015431 | Custom Drape Sheet |
| 10848340015417 | Drape Sheet |