Primary Device ID | E226100053508 |
NIH Device Record Key | 482ed630-87ca-48b9-ba70-10fbc8cc89da |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KOMET Surgical Bur |
Version Model Number | H33.316.012.G1 |
Catalog Number | H33.316.012 |
Company DUNS | 317409001 |
Company Name | Gebr. Brasseler GmbH & Co. KG |
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 | false |
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 | E226100053501 [Primary] |
HIBCC | E226100053508 [Unit of Use] |
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 | 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 |