| Primary Device ID | E226100023922 |
| NIH Device Record Key | 7aef2d00-8445-4850-9893-e3a9a717b39a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KOMET Dental Tungsten Carbide Burs |
| Version Model Number | H41SU.314.023.GS |
| Catalog Number | H41SU.314.023 |
| Company DUNS | 317409001 |
| Company Name | Gebr. Brasseler GmbH & Co. KG |
| 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 |
|---|---|
| HIBCC | E226100023921 [Primary] |
| HIBCC | E226100023922 [Package] Contains: E226100023921 Package: [25 Units] In Commercial Distribution |
| 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 | 2023-02-09 |
| Device Publish Date | 2023-02-01 |
| E226100116518 | H247F.314.009.G1 |
| E226100116508 | H134F.314.014.G1 |
| E226100112628 | H33R.314.012.G1 |
| E226100053581 | H283.314.012.A1 |
| E226100053561 | H339.314.014.A1 |
| E226100052408 | HU34.314.012.AL |
| E226100024112 | H40SU.314.012.GS |
| E226100024102 | H283SU.204.012.GS |
| E226100024092 | H283SU.314.012.GS |
| E226100024072 | H375RSU.314.018.GS |
| E226100024062 | H375RSU.314.016.GS |
| E226100024052 | H375RSU.314.014.GS |
| E226100024042 | H48LSU.314.012.GS |
| E226100024022 | H48LSU.314.010.GS |
| E226100024012 | H246SU.314.012.GS |
| E226100024002 | H246SU.314.010.GS |
| E226100023992 | H246SU.314.009.GS |
| E226100023982 | H274SU.314.018.GS |
| E226100023972 | H274SU.314.016.GS |
| E226100023952 | H247SU.314.012.GS |
| E226100023942 | H247SU.314.010.GS |
| E226100023932 | H247SU.314.009.GS |
| E226100023922 | H41SU.314.023.GS |
| E226100023912 | H41SU.314.018.GS |
| E226100023892 | H41SU.314.014.GS |
| E226100023882 | H379SU.204.023.GS |
| E226100023872 | H379SU.314.023.GS |
| E226100023862 | H379SU.314.018.GS |
| E226100023852 | H379SU.314.014.GS |
| E226100023842 | H135SU.314.014.GS |
| E226100023832 | H134SU.314.014.GS |
| E226100023822 | H133SU.314.010.GS |
| E226100023812 | H132SU.314.008.GS |
| E226100023802 | H33LSU.316.012.GS |
| E226100023792 | H33SU.314.016.GS |
| E226100023782 | H33SU.316.012.GS |
| E226100023772 | H33SU.314.012.GS |
| E226100023762 | H33SU.314.010.GS |
| E226100023752 | H33SU.314.009.GS |
| E226100023742 | H23RSU.314.012.GS |
| E226100023732 | H23LSU.314.010.GS |
| E226100023722 | H23LSU.314.009.GS |
| E226100023712 | H23SU.314.010.GS |
| E226100023702 | H23SU.314.009.GS |
| E226100023692 | H31RSSU.314.012.GS |
| E226100023682 | H31RSSU.314.010.GS |
| E226100023672 | H31SU.316.012.GS |
| E226100023662 | H31SU.314.012.GS |
| E226100023652 | H31SU.316.010.GS |
| E226100023642 | H31SSU.314.010.GS |