Gen2 G2C62338
GUDID 00840343716318
DEBAKEY VASCULAR DILATOR, 2.0MM TIP, 7.75"
SURGIX MEDICAL LLC
Vascular dilator, reusable| Primary Device ID | 00840343716318 |
| NIH Device Record Key | 4c37d582-bbfa-4365-a73c-7d769032541a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gen2 |
| Version Model Number | G2C62338 |
| Catalog Number | G2C62338 |
| Company DUNS | 080402644 |
| Company Name | SURGIX MEDICAL LLC |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com | |
| Phone | 888-247-0477 |
| customerservice@surgixmedical.com |
Device Dimensions
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
| Length | 7.75 Inch |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840343716318 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163524
FDA Product Code
| DWP | Dilator, Vessel, Surgical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
[00840343716318]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-31 |
| Device Publish Date | 2023-03-23 |
On-Brand Devices [Gen2]
| G277G2C322740 | POTTS VASCULAR SCISSORS, 5.25" |
| G277G2C312420 | DEBAKEY FORCEPS 2MM TIP 6.25" |
| G277G2N63925B0 | SPURLING KERRISON 40D UP 9" 5MM - BLACK COAT |
| G277G2N64156G0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 6MM GOLD COAT |
| G277G2N641560 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 6MM |
| G277G2N64155G0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 5MM GOLD COAT |
| G277G2N641550 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 5MM |
| G277G2N64154G0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 4MM GOLD COAT |
| G277G2N64154B0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 4MM BLACK COAT |
| G277G2N641540 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 4MM |
| G277G2N64153G0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 3MM GOLD COAT |
| G277G2N64153B0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 3MM BLACK COAT |
| G277G2N641530 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 3MM |
| G277G2N64152G0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 2MM GOLD COAT |
| G277G2N64152B0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 2MM BLACK COAT |
| G277G2N641520 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 11" 2MM |
| G277G2N640560 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 10" 6MM |
| G277G2N64055B0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 10" 5MM BLACK COAT |
| G277G2N640550 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 10" 5MM |
| G277G2N64054B0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 10" 4MM BLACK COAT |
| G277G2N640540 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 10" 4MM |
| G277G2N64053B0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 10" 3MM BLACK COAT |
| G277G2N640530 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 10" 3MM |
| G277G2N64052B0 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 10" 2MM BLACK COAT |
| G277G2N640520 | MICRO EJECTOR KERRISON, PIN TYPE 40D UP 10" 2MM |
| G277G2N639660 | WIDE MOUTH KERRISON, 9" 6MM |
| G277G2N639650 | WIDE MOUTH KERRISON, 9" 5MM |
| G277G2N639640 | WIDE MOUTH KERRISON, 9" 4MM |
| G277G2N639630 | WIDE MOUTH KERRISON, 9" 3MM |
| G277G2N639620 | WIDE MOUTH KERRISON, 9" 2MM |
| G277G2N639600 | WIDE MOUTH KERRISON, 9" 1MM |
| G277G2N63956G0 | MICRO KERRISON 40D UP 9" 6MM GOLD COAT |
| G277G2N63956B0 | MICRO KERRISON 40D UP 9" 6MM BLACK COAT |
| G277G2N639560 | MICRO KERRISON 40D UP 9" 6MM |
| G277G2N63955G0 | MICRO KERRISON 40D UP 9" 5MM GOLD COAT |
| G277G2N63955B0 | MICRO KERRISON 40D UP 9" 5MM BLACK COAT |
| G277G2N639550 | MICRO KERRISON 40D UP 9" 5MM |
| G277G2N63954G0 | MICRO KERRISON 40D UP 9" 4MM GOLD COAT |
| G277G2N63954B0 | MICRO KERRISON 40D UP 9" 4MM BLACK COAT |
| G277G2N639540 | MICRO KERRISON 40D UP 9" 4MM |
| G277G2N63953G0 | MICRO KERRISON 40D UP 9" 3MM GOLD COAT |
| G277G2N63953B0 | MICRO KERRISON 40D UP 9" 3MM BLACK COAT |
| G277G2N639530 | MICRO KERRISON 40D UP 9" 3MM |
| G277G2N63952G0 | MICRO KERRISON 40D UP 9" 2MM GOLD COAT |
| G277G2N63952B0 | MICRO KERRISON 40D UP 9" 2MM BLACK COAT |
| G277G2N639520 | MICRO KERRISON 40D UP 9" 2MM |
| G277G2N63951G0 | MICRO KERRISON 40D UP 9" 1.5MM GOLD COAT |
| G277G2N63951B0 | MICRO KERRISON 40D UP 9" 1.5MM BLACK COAT |
| G277G2N639510 | MICRO KERRISON 40D UP 9" 1.5MM |
| G277G2N63950G0 | MICRO KERRISON 40D UP 9" 1MM GOLD COAT |
Trademark Results [Gen2]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GEN2 98580935 not registered Live/Pending |
Aeronix, Inc. 2024-06-03 |
 GEN2 86736700 4913753 Live/Registered |
Outerstuff LLC 2015-08-25 |
 GEN2 86642956 not registered Dead/Abandoned |
JCM American Corporation 2015-05-27 |
 GEN2 86264029 4686038 Live/Registered |
CHART INC. 2014-04-28 |
 GEN2 86210574 4740399 Live/Registered |
Ortho Systems, Inc. 2014-03-04 |
 GEN2 85709295 4538638 Live/Registered |
OP-MARKS MEDICAL, LLC 2012-08-21 |
 GEN2 78976306 3002973 Live/Registered |
Otis Elevator Company 2003-11-17 |
 GEN2 78683090 not registered Dead/Abandoned |
FUTURELOGIC INCORPORATED 2005-08-01 |
 GEN2 78619668 3085173 Dead/Cancelled |
FLUID ROUTING SOLUTIONS, INC. 2005-04-29 |
 GEN2 78468058 3156187 Dead/Cancelled |
Humphrey Products Company 2004-08-16 |
 GEN2 78328835 not registered Dead/Abandoned |
Otis Elevator Company 2003-11-17 |
 GEN2 77675010 3760086 Live/Registered |
Quick Crete Products Corp. 2009-02-20 |
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