| Primary Device ID | 05060418832421 | 
| NIH Device Record Key | 9ad3953a-9498-4c6b-a595-e07393be9496 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Susol® Diamond Bur 1HP Enucleator | 
| Version Model Number | S-DB8 | 
| Company DUNS | 769260357 | 
| Company Name | BAILEY INSTRUMENTS LTD | 
| Device Count | 1 | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05060418832421 [Package] Contains: 05060418833749 Package: Pack [100 Units] In Commercial Distribution | 
| GS1 | 05060418833749 [Primary] | 
| GFF | Bur, Surgical, General & Plastic Surgery | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-03-06 | 
| Device Publish Date | 2024-02-27 | 
| 05060418833343 - Susol® Henckel Tilley Punch Forceps 4.5mm | 2024-05-22 | 
| 05060418833671 - Susol® Emery Board 18cm | 2024-03-06 | 
| 05060418832377 - Susol® Diamond Bur Pear 2 | 2024-03-06 | 
| 05060418832407 - Susol® Diamond Bur Pear 1 | 2024-03-06 | 
| 05060418832414 - Susol® Diamond Bur 15C | 2024-03-06 | 
| 05060418832421 - Susol® Diamond Bur 1HP Enucleator | 2024-03-06 | 
| 05060418832421 - Susol® Diamond Bur 1HP Enucleator | 2024-03-06 | 
| 05060418832674 - Susol® Blacks File SE Standard 14cm | 2024-03-06 | 
| 05060418832698 - Susol® Probe Flat Head Swan Neck 12.5cm | 2024-03-06 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SUSOL  78774087  3482237 Live/Registered | LS Industrial Systems Co., Ltd. 2005-12-15 |