| Primary Device ID | 04582275710397 |
| NIH Device Record Key | d9efbfe6-451e-4fd1-9799-60040997ed68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Basis HI |
| Version Model Number | 1kg, O PINK |
| Company DUNS | 693430001 |
| Company Name | YAMAHACHI DENTAL MFG.,CO. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 | 04582275710397 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-02-03 |
| 04582275710472 | 1kg, V PINK |
| 04582275710410 | 3kg, O PINK |
| 04582275710403 | 40g, O PINK |
| 04582275710397 | 1kg, O PINK |
| 04582594041394 | 1kg, V PINK |
| 04582594041387 | 40g*25ml, LF α |
| 04582594041370 | 40g, LF α |
| 04582594041363 | 40g, LF PINK |
| 04582594041356 | 10kg, LF PINK |
| D080XXBHIX40GXXOPN0 | 40G,O PINK |
| D080XXBHIX40GXXLFP0 | 40G,LF PINK |
| D080XXBHIX40GXXLFA0 | 40G,LF α |
| D080XXBHIX3KGXXOPN0 | 3KG,O PINK |
| D080XXBHIX1KGXXVPN0 | 1KG,V PINK |
| D080XXBHIX1KGXXOPN0 | 1KG,O PINK |
| D080XXBHI10KGXXLFP0 | 10KG,LF PINK |
| D080XXBHIX40GXXVPN0 | 40G,V PINK |
| D080XXBHIX3KGXXVPN0 | 3KG,V PINK |
| D080XXBHIX3KGXXLFP0 | 3KG,LF PINK |
| D080XXBHIX3KGXXLFA0 | 3KG,LF α |
| D080XXBHIX1KGXXLFP0 | 1KG,LF PINK |
| D080XXBHIX1KGXXLFA0 | 1KG,LF α |
| D080XXBHI4020XXVPN0 | 40G*20ML,V PINK |
| D080XXBHI4020XXOPN0 | 40G*20ML,O PINK |
| D080XXBHI4020XXLFP0 | 40G*20ML,LF PINK |
| D080XXBHI4020XXLFA0 | 40G*20ML,LF α |
| D080XXBHI10KGXXVPN0 | 10KG,V PINK |
| D080XXBHI10KGXXOPN0 | 10KG,O PINK |
| D080XXBHI10KGXXLFA0 | 10KG,LF α |
| D080XXBHI100GXXVPN0 | 100G,V PINK |
| D080XXBHI100GXXOPN0 | 100G,O PINK |
| D080XXBHI100GXXLFP0 | 100G,LF PINK |
| D080XXBHI100GXXLFA0 | 100G,LF α |