| Primary Device ID | 08806387805649 |
| NIH Device Record Key | 4ae30d41-6591-476f-942c-fee8a305cd35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gutta Percha 04-LM-35 |
| Version Model Number | 0564 |
| Company DUNS | 688322841 |
| Company Name | Meta Biomed 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 | 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806387805649 [Primary] |
| EKM | Gutta-Percha |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-03 |
| Device Publish Date | 2022-09-24 |
| 08806387808954 | Gutta Percha Points and Bars 04 taper #35, 60Points, P31R |
| 08806387807773 | Gutta Percha Points and Bars 04 taper #35, 60Points, P31S |
| 08806387806141 | Gutta Percha Points and Bars 04 taper #35, 120Points, P71 |
| 08806387805021 | Gutta Percha Points and Bars 04 taper #35, 60Points, P71 |
| 08806387805649 | Gutta Percha Points and Bars, Length Marked 04 Taper 35, Aurum Blue T3, 60 Points, P 71 |