| Primary Device ID | D690180110 |
| NIH Device Record Key | bd8e332c-954c-4eae-a958-c55fef9c62b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SSW CARBIDE FISSUROTOMY |
| Version Model Number | FG-PBUR-6004S |
| Catalog Number | 18011 |
| Company DUNS | 151760014 |
| Company Name | Ss White Burs, Inc. |
| Device Count | 10 |
| 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 | D690180110 [Unit of Use] |
| HIBCC | D690180112 [Primary] |
| EJL | BUR, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-27 |
| Device Publish Date | 2025-02-19 |
| D690102890 | FG FISSUROTOMY NTF - STERILE ROLL 100 |
| D690100520 | FG FISSUROTOMY - ROLL 100 |
| D690109150 | FG FISSUROTOMY NTF - STERILE ROLL 25 |
| D690109140 | FG FISSUROTOMY - STERILE ROLL 25 |
| D690131000 | FG FISSUROTOMY NTF - BULK 100 |
| D690130990 | FG FISSUROTOMY STF - BULK 100 |
| D690130980 | FG FISSUROTOMY SHORT SHANK - BULK 100 |
| D690130970 | FG FISSUROTOMY - BULK 100 |
| D690109320 | FG FISSUROTOMY STF - STERILE ROLL 25 |
| D690647512 | FG FISSUROTOMY NTF SAMPLE - 1 PACK |
| D690647502 | FG FISSUROTOMY STF SAMPLE - 1 PACK |
| D690647482 | FG FISSUROTOMY ORIGINAL SAMPLE - 1 PACK |
| D690180172 | FISSUROTOMY PRO SAMPLE SHORT SHANK 6004S |
| D6901801650 | FG FISSUROTOMY NTF SHORT SHANK - 5 PACK |
| D690180160 | FG FISSUROTOMY NTF SHORT SHANK - 10 PACK |
| D6901801550 | FG FISSUROTOMY STF SHORT SHANK - 5 PACK |
| D690180150 | FG FISSUROTOMY STF SHORT SHANK - 10 PACK |
| D6901801450 | FG FISSUROTOMY NTF - 5 PACK |
| D690180140 | FG FISSUROTOMY NTF - 10 PACK |
| D6901801350 | FG FISSUROTOMY STF - 5 PACK |
| D690180130 | FG FISSUROTOMY STF - 10 PACK |
| D690180122 | FG FISSUROTOMY PRO SAMPLE 6004 - 1 PACK |
| D6901801150 | FG FISSUROTOMY SHORT SHANK - 5 PACK |
| D690180110 | FG FISSUROTOMY SHORT SHANK - 10 PACK |
| D690180100 | FG FISSUROTOMY - 10 PACK |
| D6901800651 | FG SNCLF - 5 PACK |
| D6901800551 | FG NCLF - 5 PACK |
| D6901800451 | FG CLF- 5 PACK |