| Primary Device ID | 00851913006418 |
| NIH Device Record Key | 1a14c8c2-af85-41bc-98c0-cdad903f909e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PALS X |
| Version Model Number | PX2040 |
| Company DUNS | 150959401 |
| Company Name | AXELGAARD MANUFACTURING CO., LTD. |
| 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 | 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 | true |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851913006418 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-20 |
| Device Publish Date | 2024-12-12 |
| 00851913006418 | PALS X 2" x 4" rectangle |
| 00851913006401 | PALS X 2" x 2" square |