| Primary Device ID | E226023273A11 |
| NIH Device Record Key | 7f42a599-ae24-49b4-8dbb-65c0fa3e3a15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KOMET Surgical Bur |
| Version Model Number | 163RF.104.014.A1 |
| Catalog Number | 163RF.104.014 |
| Company DUNS | 317409001 |
| Company Name | Gebr. Brasseler GmbH & Co. KG |
| Device Count | 1 |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E226023273A11 [Primary] |
| GFF | BUR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E226023273A11]
Moist Heat or Steam Sterilization
[E226023273A11]
Moist Heat or Steam Sterilization
[E226023273A11]
Moist Heat or Steam Sterilization
[E226023273A11]
Moist Heat or Steam Sterilization
[E226023273A11]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2023-02-01 |
| E226100053508 | H33.316.012.G1 |
| E226048358A22 | H48LUF.310.023.A2 |
| E226048357A22 | H48LUF.310.014.A2 |
| E226048356A22 | H379UF.310.023.A2 |
| E226048355A22 | H379UF.310.014.A2 |
| E226048354A22 | H48L.310.023.A2 |
| E226048353A22 | H48L.310.014.A2 |
| E226048352A22 | H379.310.023.A2 |
| E226048351A22 | H379.310.014.A2 |
| E226047419A11 | H162ST.314.016.A1 |
| E226047418A11 | H162ST.104.016.A1 |
| E226046557A11 | H255E.104.012.A1 |
| E226046555A28 | H255E.316.012.A2 |
| E226046555A11 | H255E.316.012.A1 |
| E226046554A28 | H255E.314.012.A2 |
| E226046554A11 | H255E.314.012.A1 |
| E226043962A28 | H2033R.310.016.A2 |
| E226041167A28 | H33S.310.016.A2 |
| E226040755A28 | H207D.316.012.A2 |
| E226036584A11 | H254E.104.012.A1 |
| E226034907A11 | K160A.205.027.A1 |
| E226034906A11 | K160A.205.031.A1 |
| E226034905A11 | K160A.104.027.A1 |
| E226034903A11 | K160A.104.031.A1 |
| E226034575A11 | K160A.205.023.A1 |
| E226034574A11 | K160A.104.023.A1 |
| E226031156AU8 | H2033RA.310.016.AU |
| E226023273A11 | 163RF.104.014.A1 |
| E226021291G18 | H33RS.316.021.G1 |
| E226021291A28 | H33RS.316.021.A2 |
| E226021289G18 | H33RS.316.016.G1 |
| E226021289A28 | H33RS.316.016.A2 |
| E226021285A28 | H33S.316.016.A2 |
| E226021175A28 | H1.310.018.A2 |
| E226018762A11 | NC0922.014..A1 |
| E226018759A11 | NC0921.003..A1 |
| E226018758A11 | NC0921.014..A1 |
| E226018316A11 | NC0901.014..A1 |
| E226017146A11 | 168RF.104.023.A1 |
| E226016035A28 | H1.206.014.A2 |
| E226016025A11 | H162A.314.016.A1 |
| E226015854A28 | H379.316.018.A2 |
| E226015847A28 | H41.316.014.A2 |
| E226015797A28 | H379.316.014.A2 |
| E226015389AU8 | H390.316.016.AU |
| E226015389A28 | H390.316.016.A2 |
| 24053613283841 | S2726.098..M0 |
| 24053613279509 | NS3706.027..M2 |
| 24053613279493 | NS3805.027..M2 |
| 24053613279486 | NS3804.027..M2 |