| Primary Device ID | 08806387806141 | 
| NIH Device Record Key | 5a9ae27f-7d83-4790-8f39-4bad795c1ba1 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Gutta Percha 04-LM-35 | 
| Version Model Number | 0614 | 
| 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 | 08806387806141 [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 | 
| 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 |