| Primary Device ID | H6680921831F1 |
| NIH Device Record Key | fc5b82ba-19cf-4afe-bc30-47b4939e1f78 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bosworth Supergel Fresh |
| Version Model Number | 0921831F |
| Catalog Number | 0921831F |
| Company DUNS | 014769301 |
| Company Name | Harry J Bosworth Company |
| 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 | false |
| 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 |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com |
| Weight | 25 Pound |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H6680921831F1 [Primary] |
| ELW | MATERIAL, IMPRESSION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-26 |
| H6680921839SR1 | Alginate Impression Pwd. Fresh Reg Set Sample |
| H6680921839SF1 | Alginate Impression Pwd. Fresh Fast Set Sample |
| H6680921832F1 | Alginate Impression Pwd low dust 25 lb Fast Set |
| H6680921831F1 | Alginate Impression Pwd low dust 25 lb Reg Set |
| H66809218301 | Alginate Impression Pwd low dust 1 lb bag, Fast Set |
| H66809218271 | Alginate Impression Pwd low dust 1 lb bag, Reg. Set |
| H66809218231 | Alginate Impression Pwd low dust 1 lb Can, Fast Set |
| H66809218221 | Alginate Impression Pwd low dust 1 lb Can, Reg. Set |