| Primary Device ID | 00860014142499 |
| NIH Device Record Key | 9d46e78b-ea00-43ee-bff3-07738be52237 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TCMzone HuoTuo |
| Version Model Number | TIK-0.25mm x 40mm |
| Catalog Number | TIK-0.25mm x 40mm (#32) |
| Company DUNS | 007842633 |
| Company Name | TCMZone, LLC |
| Device Count | 1000 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 00860014142451 [Primary] |
| GS1 | 00860014142499 [Unit of Use] |
| MQX | Needle, Acupuncture, Single Use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-08 |
| Device Publish Date | 2025-06-30 |
| 00860014142475 | Disposable acupuncture needle, 0.20mm × 30mm (#36), with spring handle and guide tube. Sterile, |
| 00860014142499 | Disposable acupuncture needle, 0.25mm × 40mm (#32), with spring handle and guide tube. Sterile, |
| 00860014142482 | Disposable acupuncture needle, 0.22mm × 40mm (#34), with spring handle and guide tube. Sterile, |