| Primary Device ID | 00858298006569 |
| NIH Device Record Key | 9369cfb6-d5c4-4183-b342-880371b55987 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Replacement Gen 3 21mm Flange |
| Version Model Number | FR42159 |
| Company DUNS | 050917861 |
| Company Name | EXPLORAMED NC7, 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858298006569 [Primary] |
| HGX | Pump, Breast, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-17 |
| Device Publish Date | 2020-03-09 |
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