TruClear 72204878
GUDID 10884521746633
Elite Hysteroscope Mini
Covidien LP
Rigid optical hysteroscope| Primary Device ID | 10884521746633 |
| NIH Device Record Key | 2dd1250f-aff8-4fd9-996f-121e0f3ca131 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruClear |
| Version Model Number | 72204878 |
| Catalog Number | 72204878 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 | false |
| Serial Number | true |
| 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 |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521746633 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180496
FDA Product Code
| HIH | HYSTEROSCOPE (AND ACCESSORIES) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
[10884521746633]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-10 |
| Device Publish Date | 2018-12-21 |
On-Brand Devices [TruClear]
| 00885556583685 | Operative Sheath 5C |
| 00885556583654 | Operative Hysteroscope 5C |
| 10884521749917 | Control Unit, Refurbished |
| 10884521749900 | Handpiece, Refurbished |
| 10884521749931 | Control Unit |
| 10884521767744 | Elite Hysteroscope Mini, Refurbished |
| 10884521767737 | Elite Hysteroscope Plus, Refurbished |
| 20884521750200 | Elite Hysteroscope Seal |
| 10884521746657 | Elite Working Channel Insert Mini |
| 10884521746640 | Elite Working Channel Insert Plus |
| 10884521746633 | Elite Hysteroscope Mini |
| 10884521746626 | Elite Hysteroscope Plus |
| 10884521749948 | Footswitch |
| 10884521749924 | Handpiece |
| 10884521746763 | Sheath |
| 10884521746695 | Operative Hysteroscope 5C, Refurbished |
| 10884521746671 | Operative Hysteroscope, Refurbished |
| 10884521746664 | Operative Hysteroscope |
| 10884521746756 | Sheath 5C |
| 10884521746688 | Operative Hysteroscope 5C |
| 10884521744158 | Instrument Tray |
| 10884521746749 | Obturator |
| 10884521746732 | Sheath |
| 90884521744093 | Dense Tissue Shaver Mini |
| 90884521744116 | Dense Tissue Shaver Plus |
| 90884521744109 | Soft Tissue Shaver Plus |
| 90884521744086 | Soft Tissue Shaver Mini |
| 10884521724709 | Hysteroscope Seal Cap |
| 10884521744141 | Calibration Insert |
| 10884521744134 | Calibration Insert |
Trademark Results [TruClear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUCLEAR 97148479 not registered Live/Pending |
TruClear Water Solutions, Inc. 2021-11-30 |
 TRUCLEAR 90904898 not registered Live/Pending |
Ruchin Holdings, LLC 2021-08-26 |
 TRUCLEAR 88237400 not registered Live/Pending |
Tastes Natural, LLC 2018-12-20 |
 TRUCLEAR 88151660 5811042 Live/Registered |
Vision Source L.P. 2018-10-11 |
 TRUCLEAR 86374038 4973831 Live/Registered |
ZODIAC POOL SYSTEMS LLC 2014-08-21 |
 TRUCLEAR 85409627 not registered Dead/Abandoned |
Belkin International, Inc. 2011-08-29 |
 TRUCLEAR 85018725 not registered Dead/Abandoned |
Teva Respiratory, LLC 2010-04-20 |
 TRUCLEAR 78523459 not registered Dead/Abandoned |
QLT USA, Inc. 2004-11-29 |
 TRUCLEAR 77808763 3975189 Live/Registered |
COVIDIEN LP 2009-08-20 |
 TRUCLEAR 77125908 3496554 Live/Registered |
Vision Source L.P. 2007-03-08 |
 TRUCLEAR 74003198 1627874 Dead/Cancelled |
ANALYTICAL DEVELOPMENT CORPORATION 1989-11-17 |
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