| Primary Device ID | 10848340009300 |
| NIH Device Record Key | aae204d4-1c8f-4e41-8a8b-6a777bf62613 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNBRANDED |
| Version Model Number | FF548NS |
| 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 | 00848340009303 [Primary] |
| GS1 | 10848340009300 [Package] Contains: 00848340009303 Package: [100 Units] In Commercial Distribution |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10848340009300]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-19 |