| Primary Device ID | 08806387805403 |
| NIH Device Record Key | fc5e73b5-e3be-488e-9b4c-09ee3dabb67d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gutta Percha 08-LM-15/40 |
| Version Model Number | 0540 |
| 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 | 08806387805403 [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 |
| 08806387814603 - MX 02-15 | 2025-09-03 MGP, 02 Taper 15, 60 Points, P.71 |
| 08806387814610 - MX 02-20 | 2025-09-03 MGP, 02 Taper 20, 60 Points, P.71 |
| 08806387814627 - MX 02-25 | 2025-09-03 MGP, 02 Taper 25, 60 Points, P.71 |
| 08806387814634 - MX 02-30 | 2025-09-03 MGP, 02 Taper 30, 60 Points, P.71 |
| 08806387814641 - MX 02-35 | 2025-09-03 MGP, 02 Taper 35, 60 Points, P.71 |
| 08806387814658 - MX 02-40 | 2025-09-03 MGP, 02 Taper 40, 60 Points, P.71 |
| 08806387814665 - MX 04-15 | 2025-09-03 MGP, 04 Taper 15, 60 Points, P.71 |
| 08806387814672 - MX 04-20 | 2025-09-03 MGP, 04 Taper 20, 60 Points, P.71 |