| Primary Device ID | 08806387806158 |
| NIH Device Record Key | e88612c0-87ea-4ca8-8de5-bd60302645ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gutta Percha 04-LM-40 |
| Version Model Number | 0615 |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806387806158 [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 | 2021-06-10 |
| Device Publish Date | 2021-06-02 |
| 08806387808961 | Gutta Percha Points and Bars 04 taper #40, 60Points, P31R |
| 08806387807780 | Gutta Percha Points and Bars 04 taper #40, 60Points, P31S |
| 08806387806158 | Gutta Percha Points and Bars 04 taper #40, 120Points, P71 |
| 08806387805038 | Gutta Percha Points and Bars 04 taper #40, 60Points, P71 |
| 08806387805656 | Gutta Percha Points and Bars, Length Marked 04 Taper 40, Aurum Blue T4, 60 Points, P 71 |