| Primary Device ID | D877A020STC250 |
| NIH Device Record Key | c751e701-c166-44e5-8f68-3dc77b9efaf3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Strauss One |
| Version Model Number | A020ST/C |
| Catalog Number | A020ST/C |
| Company DUNS | 600028195 |
| Company Name | STRAUSS & CO - INDUSTRIAL DIAMONDS LTD |
| Device Count | 25 |
| 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 |
|---|---|
| HIBCC | D877A020STC25 [Primary] |
| HIBCC | D877A020STC250 [Unit of Use] |
| DZP | Instrument, Diamond, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-31 |
| Device Publish Date | 2025-12-23 |
| D877A020STC250 - Strauss One | 2025-12-31Sterilized Round Diamond Bur Coarse Grit |
| D877A020STC250 - Strauss One | 2025-12-31 Sterilized Round Diamond Bur Coarse Grit |
| D87745080FGCERK0RPACED1 - Ceramic Dental bur | 2025-12-24 Optimum® Ceramic Soft Tissue Trimmer - Implant Uncovering Bur - Small |
| D87745080FGCERK2RPACED1 - Ceramic Dental bur | 2025-12-24 Optimum® Ceramic Soft Tissue Trimmer - Implant Uncovering Bur - Big |
| D87748786P01D2521 - dental diamond bur | 2025-12-24 P.O. 4.2(3.6 blank)X31X2.35X53 DR. ZGDB3542MQ + COLORING + LASER |
| D87748786P02D4271 - dental diamond bur | 2025-12-24 P.O. 4.2(4.2 blank)X31X2.35X53 DR. ZGDB3542CQ + COLORING + LASER |
| D87748786P031 - dental diamond bur | 2025-12-24 4.2(4.2 blank)X31X2.35X53 DR. ZGDB3542CQ NP252473 |
| D87748786P03D4271 - dental diamond bur | 2025-12-24 4.2(4.2 blank)X31X2.35X53 DR. ZGDB3542CQ + COLORING + LASER NP252473 |
| D87748786P041 - dental diamond bur | 2025-12-24 4.2(3.6 blank)X31X2.35X53 DR. ZGDB3542MQ NP252472 |