Primary Device ID | B351680030 |
NIH Device Record Key | e71a5e1c-9570-4374-acc1-4ce2ef272839 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ENDO-EAR |
Version Model Number | 6.80.03 |
Catalog Number | 6.80.03 |
Company DUNS | 015903922 |
Company Name | Mytamed, Inc. |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 | B351680030 [Primary] |
JYO | Knife, Ear |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B351680030]
Moist Heat or Steam Sterilization
[B351680030]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2018-01-25 |
B351EE10010 | ENDO-EAR Instrument Tray |
B351EE10000 | ENDO-EAR Endoscope Tray |
B351EE03700 | ENDO-EAR Endoscope, 3mm x 150mm, 70 Deg. |
B351EE03450 | ENDO-EAR Endoscope, 3mm x 150mm, 45 Deg. |
B351EE03300 | ENDO-EAR Endoscope, 3mm x 150mm, 30 Deg. |
B351EE03000 | ENDO-EAR Endoscope, 3mm x 150mm, 0 Deg. |
B351680100 | LEE No.9 Dissector, Double-Ended, Short and Long 1.5mm Paddles |
B351680090 | LEE No.9 Dissector, Double-Ended, Short and Long 1.0mm Paddles |
B351680080 | LEE No.8 Dissector, Double-Ended, Right and Left Curved Blades |
B351680070 | LEE No.7 Dissector, Double-Ended, 3mm and 5mm Blades |
B351680060 | LEE No.6 Suction Dissector, 1.0 x 1.5mm, 1.0mm Suction to Tip |
B351680050 | LEE No.5 Suction Dissector, 2.5mm Round, 0.5mm Suction to Tip |
B351680040 | LEE No.4 Suction Dissector, 2.0mm Round, 0.5mm Suction to Tip |
B351680030 | LEE No.3 Suction Dissector, 1.0 x 1.5mm, 1.5mm Suction to Tip |
B351680020 | LEE No.2 Suction Dissector, 2.5mm Round, 1.0mm Suction to Tip |
B351680010 | LEE No.1 Suction Dissector, 2.0mm Round, 1.0mm Suction to Tip |
B351196200 | ENDO-EAR Suction, Long Curve, 20 Ga, Left |
B351196030 | ENDO-EAR Suction, Long Curve, 3 Fr, Left |
B351195200 | ENDO-EAR Suction, Long Curve, 20 Ga, Right |
B351195030 | ENDO-EAR Suction, Long Curve, 3 Fr, Right |
B351194240 | ENDO-EAR Suction, Medium Curve, 24 Ga, Left |
B351194200 | ENDO-EAR Suction, Medium Curve, 20 Ga, Left |
B351194050 | ENDO-EAR Suction, Medium Curve, 5 Fr, Left |
B351194030 | ENDO-EAR Suction, Medium Curve, 3 Fr, Left |
B351193240 | ENDO-EAR Suction, Medium Curve, 24 Ga, Right |
B351193200 | ENDO-EAR Suction, Medium Curve, 20 Ga, Right |
B351193050 | ENDO-EAR Suction, Medium Curve, 5 Fr, Right |
B351193030 | ENDO-EAR Suction, Medium Curve, 3 Fr, Right |
B351192240 | ENDO-EAR Suction, Short Curve, 24 Ga, Left |
B351192200 | ENDO-EAR Suction, Short Curve, 20 Ga, Left |
B351192050 | ENDO-EAR Suction, Short Curve, 5 Fr, Left |
B351192030 | ENDO-EAR Suction, Short Curve, 3 Fr, Left |
B351191240 | ENDO-EAR Suction, Short Curve, 24 Ga, Right |
B351191200 | ENDO-EAR Suction, Short Curve, 20 Ga, Right |
B351191050 | ENDO-EAR Suction, Short Curve, 5 Fr, Right |
B351191030 | ENDO-EAR Suction, Short Curve, 3 Fr, Right |
B351186200 | ENDO-EAR Suction, Long Curve, 20 Ga, Down |
B351186030 | ENDO-EAR Suction, Long Curve, 3 Fr, Down |
B351185200 | ENDO-EAR Suction, Long Curve, 20 Ga, Up |
B351185030 | ENDO-EAR Suction, Long Curve, 3 Fr, Up |
B351184240 | ENDO-EAR Suction, Medium Curve, 24 Ga, Down |
B351184200 | ENDO-EAR Suction, Medium Curve, 20 Ga, Down |
B351184050 | ENDO-EAR Suction, Medium Curve, 5 Fr, Down |
B351184030 | ENDO-EAR Suction, Medium Curve, 3 Fr, Down |
B351183240 | ENDO-EAR Suction, Medium Curve, 24 Ga, Up |
B351183200 | ENDO-EAR Suction, Medium Curve, 20 Ga, Up |
B351183050 | ENDO-EAR Suction, Medium Curve, 5 Fr, Up |
B351183030 | ENDO-EAR Suction, Medium Curve, 3 Fr, Up |
B351182240 | ENDO-EAR Suction, Short Curve, 24 Ga, Up |
B351182200 | ENDO-EAR Suction, Short Curve, 20 Ga, Down |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDO-EAR 86940685 5282084 Live/Registered |
GRACE MEDICAL, INC. 2016-03-15 |