| Primary Device ID | D690201000 |
| NIH Device Record Key | de41adf2-83e1-46df-a7af-e281854222c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SSW CARBIDE ENDO GUIDE |
| Version Model Number | FG-PBUR-6004SL |
| Catalog Number | 20100 |
| Company DUNS | 151760014 |
| Company Name | Ss White Burs, Inc. |
| Device Count | 5 |
| DM Exempt | true |
| 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 | false |
| 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 | D690201000 [Unit of Use] |
| HIBCC | D690201002 [Primary] |
| EJL | BUR, 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 | 2025-02-27 |
| Device Publish Date | 2025-02-19 |
| D690647492 | ENDOGUIDE FG CARBIDE EG1A - 1 PACK |
| D690357650 | ENDOGUIDE RA CARBIDE EG7 -5 PACK |
| D690357640 | ENDOGUIDE RA CARBIDE EG6 -5 PACK |
| D690357630 | ENDOGUIDE RA CARBIDE EG5 -5 PACK |
| D690357620 | ENDOGUIDE FG CARBIDE EG4 -5 PACK |
| D690357610 | ENDOGUIDE FG CARBIDE EG3 -5 PACK |
| D690357600 | ENDOGUIDE RA CARBIDE EG2 -5 PACK |
| D690357590 | ENDOGUIDE RA CARBIDE EG1 - 5 PACK |
| D690357580 | ENDOGUIDE FG CARBIDE EG1A -5 PACK |
| D690201050 | ENDOGUIDE RA CARBIDE EG5 - STERILE 5 PACK |
| D690201040 | ENDOGUIDE FG CARBIDE EG4 - STERILE 5 PACK |
| D690201030 | ENDOGUIDE FG CARBIDE EG3 - STERILE 5 PACK |
| D690201020 | ENDOGUIDE RA CARBIDE EG2 - STERILE 5 PACK |
| D690201010 | ENDOGUIDE 1 EG#1 Sterile |
| D690201000 | ENDOGUIDE FG CARBIDE EG1A - STERILE 5 PACK |
| D690150660 | ENDOGUIDE FG CARBIDE EG1A - 5 PACK |
| D690150290 | ENDOGUIDE FG CARBIDE EG4 -5 PACK |
| D690150230 | ENDOGUIDE FG CARBIDE EG3 -5 PACK |
| D690147950 | ENDOGUIDE RA CARBIDE EG6 -5 PACK |
| D690147940 | ENDOGUIDE RA CARBIDE EG5 -5 PACK |
| D690147860 | ENDOGUIDE RA CARBIDE EG7 -5 PACK |
| D690147800 | ENDOGUIDE RA CARBIDE EG1 - 5 PACK |
| D690147790 | ENDOGUIDE RA CARBIDE EG2 -5 PACK |