ENDO-EAR EE-1000
GUDID B351EE10000
ENDO-EAR Endoscope Tray
Mytamed, Inc.
Instrument tray| Primary Device ID | B351EE10000 |
| NIH Device Record Key | 83739dee-60c2-4d24-8653-3a795f79c5bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDO-EAR |
| Version Model Number | EE-1000 |
| Catalog Number | EE-1000 |
| Company DUNS | 015903922 |
| Company Name | Mytamed, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B351EE10000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133015
FDA Product Code
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
[B351EE10000]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Peracetic Acid
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-25 |
On-Brand Devices [ENDO-EAR]
| 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 |
Trademark Results [ENDO-EAR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDO-EAR 86940685 5282084 Live/Registered |
GRACE MEDICAL, INC. 2016-03-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.