| Primary Device ID | 08809939930691 |
| NIH Device Record Key | 12f8dc42-0d71-4f81-828d-9632222efba1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CareCellve Wave Plus |
| Version Model Number | HBLA-ZA-001 |
| Company DUNS | 688299527 |
| Company Name | General Bio Co., Ltd. |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| 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 | false |
| Phone | 213-7602878 |
| Info.us@gcoop.com | |
| Phone | 213-7602878 |
| Info.us@gcoop.com | |
| Phone | 213-7602878 |
| Info.us@gcoop.com | |
| Phone | 213-7602878 |
| Info.us@gcoop.com | |
| Phone | 213-7602878 |
| Info.us@gcoop.com | |
| Phone | 213-7602878 |
| Info.us@gcoop.com | |
| Phone | 213-7602878 |
| Info.us@gcoop.com | |
| Phone | 213-7602878 |
| Info.us@gcoop.com | |
| Phone | 213-7602878 |
| Info.us@gcoop.com | |
| Phone | 213-7602878 |
| Info.us@gcoop.com | |
| Phone | 213-7602878 |
| Info.us@gcoop.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809939930691 [Primary] |
| ISA | Massager, Therapeutic, Electric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-10 |
| Device Publish Date | 2025-09-02 |