ELMED 5756

GUDID 00842180105997

ELMED ESU 400 WITH SMART-O-MATIC CIRCUIT, MONOPOLAR AND BIPOLAR

ELMED INCORPORATED

Electrosurgical system generator

• Primary Device ID: 00842180105997
• NIH Device Record Key: 0c6997f7-b6e3-4440-952b-21f2d8f837d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELMED
• Version Model Number: 5756
• Catalog Number: 5756
• Company DUNS: 049290364
• Company Name: ELMED INCORPORATED
• 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: 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: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842180105997 [Primary]

FDA Product Code

• BWA: Unit, Electrosurgical Andcoagulation, With Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-29

On-Brand Devices [ELMED]

• 00842180135833: ELMED SINUS BIPOLAR FORCEPS W/SUCTION, 105MM WORKING LENGTH
• 00842180135826: 10 MM DIA., 36CM RIGHT ANGLE MIXTER, LONG, INSULATED SHAFT & HANDLE W/ RF-POST, ROTATABLE-ONE PI
• 00842180135819: FAZIER SUCTION TUBES, ANGULAR, INSULATES, WITH MONOPOLAR RF-CONNECTOR, 9" (228MM), REUSABLE, 15
• 00842180135802: 6 FR. DOME TIP, ELMED FLEXIBLE ELECTRODE FOR FLEXIBLE URETEROSCOPES AND CYSTOSCOPES, (* SPECIFY
• 00842180135796: 7 FR. DOME TIP, ELMED FLEXIBLE ELECTRODE FOR FLEXIBLE CYSTOSCOPES AND URETEROSCOPES (*SPECIFY WO
• 00842180135789: 5 MM DIA., 45 CM INSULATED BUTTON ELECTRODE, REAR MOUNT RF-CONNECTOR
• 00842180135772: 3MM DIA., 32CM, HEAVY SERRATED GRASPER, INSULATED SHAFT & HANDLE W/RF-POST, ROTATABLE-ONE PIECE
• 00842180135765: 5MM DIA, 13 CM , ENDOPLASTIC GRASPING FORCEPS, 30 DEG. ANGLED, INSULATED SHAFT & HANDLE W/RF-POS
• 00842180135758: FOOT-SWITCHING MONOPOLAR FORCEPS: CUSHING, 7 3/4" (19.5CM) LONG, SMOOTH STRAIGHT TIP, 4MM FEMALE
• 00842180135741: 5 MM DIA., 34 CM BIPOLAR FORCEPS, ROTATABLE, WITH FLAT PADDLE TIP AND RING HANDLE
• 00842180135734: FAZIER SUCTION TUBES, ANGULAR, INSULATES, WITH MONOPOLAR RF-CONNECTOR, 9" (228MM), REUSABLE, 12
• 00842180135727: 12MM, 103MM ELMD "LITE" THERMOPLASTIC TROCAR SLEEVE
• 00842180135710: ELMED BIPOLAR SURGICAL SCISSORS, CURVED MICRO, 14CM (5.50"), ROUND TIP BLADES, HEAVY DUTY SYNTHE
• 00842180135703: ELMED BIPOLAR SURGICAL SCISSORS, CURVED MICRO, 13CM (5.25"), ROUND TIP BLADES, HEAVY DUTY SYNTHE
• 00842180135697: 5 MM DIA., 45 CM BIPOLAR LAPAROSCOPIC FORCEPS, SPRING HANDLE TYPE III, FLAT TIP, (FLAT PADDLE TI
• 00842180135680: ELMED MICRO BIPOLAR FORCEPS, 2-PIN CONNECTOR, JEWELERS STRAIGHT, 4 1/4" (9CM) INSULATED, STRAIGH
• 00842180135673: ADAPTER 8MM MALE BOVIE PLUG AND DISPOSABLE INSTRUMENT CONNECTOR
• 00842180135666: HAND ACTIVATED MONOPOLAR FORCEPS, 9" (23CM), STRAIGHT, GOLD PLATED TIP, W/ATTACHED 10-FT. CABL
• 00842180135659: 5 MM DIA., 32 CM BIPOLAR LAPAROSCOPIC FORCEPS, SPRING HANDLE TYPE III, FLAT TIP, (FLAT PADDLE TI
• 00842180135642: 10 MM DIA., 45 CM, ELMED BARIARTRIC LAPAROSCOPE, 0 DEGREE VIEWING, PREMIUM ROD LENS SYSTEM, AUTO
• 00842180135635: 5MM DIA., 45CM, ELMED BARIATRIC LAPAROSCOPE, 45 DEGREE VIEWING, PREMIUM ROD LENS SYSTEM, AUTOCLA
• 00842180135628: 5MM DIA., 45CM, ELMED BARIATRIC LAPAROSCOPE, 30 DEGREE VIEWING, PREMIUM ROD LENS SYSTEM, AUTOCLA
• 00842180135611: 5MM DIA., 45CM, ELMED BARIATRIC LAPAROSCOPE, 0 DEGREE VIEWING, PREMIUM ROD LENS SYSTEM, AUTOCLAV
• 00842180135598: 10 MM DIA., 30 CM, ELMED LAPAROSCOPE, 0 DEGREE VIEWING, ACHROMAT LENS SYSTEM, AUTOCLAVABLE
• 00842180135581: 10 MM DIA., 33 CM, ELMED LAPAROSCOPE, 45 DEGREE VIEWING, PREMIUM ROD LENS SYSTEM, AUTOCLAVABLE
• 00842180135574: 10 MM DIA., 33 CM, ELMED LAPAROSCOPE, 30 DEGREE VIEWING, PREMIUM ROD LENS SYSTEM, AUTOCLAVABLE
• 00842180135567: ELMED BIPOLAR TRIPLE FUNCTION FORCEPS, 30 CM LONG, 10 MM DIA.
• 00842180135550: 10 MM DIA., 33 CM, ELMED LAPAROSCOPE, 0 DEGREE VIEWING, PREMIUM ROD LENS SYSTEM, AUTOCLAVABLE
• 00842180135543: ELMED OPERATING LAPAROSCOPE, 0 DEGREE RIGHT ANGLE EYE PIECE, 12 MM DIA., 27 CM LENGTH, 7 MM DIA.
• 00842180135536: 10MM 36CM RIGHT ANGLE MIXTER, LONG , TYPE 1: INSULATED STAINLESS STEEL W/ RF POST, ROTATABLE, ON
• 00842180135529: 5MM DIA., 36CM, PETELIN DISSECTOR, STRONG RIGHT ANGLE-INSULATED SHAFT & HANDLE W/ RF-POST, MODUL
• 00842180135512: FAZIER SUCTION TUBES, ANGULAR, INSULATES, WITH MONOPOLAR RF-CONNECTOR, 11" (280MM), REUSABLE, 14
• 00842180135505: FAZIER SUCTION TUBES, ANGULAR, INSULATES, WITH MONOPOLAR RF-CONNECTOR, 11" (280MM), REUSABLE, 12
• 00842180135499: ELMED FRAZIER MONOPOLAR SUCTION COAGULATOR, ANGULAR, INSULATED, W/ RF-CONNECTOR, 14" (355MM), RE
• 00842180135482: BIPOLAR JUMPER CABLE FOR VALLEYLAB UNITS, 48'' LONG, TWO 4MM BANANA PLUGS ON EACH END
• 00842180135468: 3 MM DIA., 33 CM INSULATED L-HOOK ELECTRODE, SIDE RF POST
• 00842180135451: 3 MM DIA., 33 CM BIPOLAR SPOT COAGULATOR PROBE W/ STOPCOCK
• 00842180135444: 3 MM DIA., 33 CM INSULATED NEEDLE ELECTRODE, SIDE RF POST
• 00842180135420: 3 MM DIA., 33 CM INSULATED J-HOOK ELECTRODE, SIDE RF POST
• 00842180135413: 3 MM DIA., 33 CM INSULATED BUTTON ELECTRODE, SIDE RF POST
• 00842180135406: 3 MM DIA., 33 CM INSULATED CONE ELECTRODE, SIDE RF POST
• 00842180135390: 3 MM DIA., 33 CM INSULATED KNIFE ELECTRODE, SIDE RF POST
• 00842180135383: 5MM DIA., 34CM, ELMED POWERGRIP BIPOLAR CLAW FORCEPS.(COMPLETE - HANDLE, INSERT, SHAFT). MODULAR
• 00842180135376: 5MM DIA., 34CM, ELMED POWERGRIP BIPOLAR LAP. DELTA GRASPING FORCEPS. (COMPLETE - HANDLE, INSERT,
• 00842180135369: 5MM DIA., 34CM, ELMED POWERGRIP BIPOLAR LAP. PIN - POINT COAGULATING FORCEPS. (COMPLETE - HANDLE
• 00842180135352: 5MM DIA., 34CM, ELMED POWERGRIP BIPOLAR LAP. LARGE GRASPING FORCEPS. (COMPLETE - HANDLE, INSERT,
• 00842180135345: 5MM DIA., 34CM, ELMED POWERGRIP BIPOLAR LAP. MARYLAND FORCEPS. (COMPLETE - HANDLE, INSERT, SHAFT
• 00842180135338: 5MM DIA., 34CM, ELMED POWERGRIP BIPOLAR LAP. SCISSORS, CURVED (COMPLETE - HANDLE, INSERT, SHAFT
• 00842180135321: 5MM, 34CM ELMED POWERGRIP SHAFT
• 00842180135314: ELMED POWERGRIP BIPOLAR HANDLE