Macan

GUDID 00853404007522

iSurg Electrosurgical Unit (Complete Kit)

Macan Manufacturing

Electrosurgical system

• Primary Device ID: 00853404007522
• NIH Device Record Key: 1d4476ab-bc39-4d17-ab48-6b3b78ae1d37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Macan
• Version Model Number: MC-IS
• Company DUNS: 962296062
• Company Name: Macan Manufacturing
• 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: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com
• Phone: 302-645-8068
• Email: info@macanmanufacturing.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853404007522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170054

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

[00853404007522]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-26
• Device Publish Date: 2018-10-25

On-Brand Devices [Macan]

• 00853404007539: iVac Smoke Evacuator
• 00853404007522: iSurg Electrosurgical Unit (Complete Kit)
• 00853404007515: Flexible Dispersive Plate only, plastic coated 7" x 11", not autoclaveable
• 00853404007508: Dispersive Plate CORD ONLY, 12' length, autoclavable (RED)
• 00851708006647: Foot Pedal
• 00851708006630: Power Cord
• 00851708006166: UFSSD-6 Electrode Set (6 pk)
• 00851708006159: UFSSD-5 Electrode Set (5 pk)
• 00851708006142: UF-L40 Electrode (2 pk)
• 00851708006135: UF-L30 Electrode (2 pk)
• 00851708006128: UF-SN62 Electrode (2 pk)
• 00851708006111: UF-SN61 Electrode (2 pk)
• 00851708006104: UF-L45 Electrode (2 pk)
• 00851708006098: UF-L42 Electrode (2 pk)
• 00851708006081: UF-L37 Electrode (2 pk)
• 00851708006074: UF-L36 Electrode (2 pk)
• 00851708006067: UF-L35 Electrode (2 pk)
• 00851708006050: UF-L34 Electrodes (2 pk)
• 00851708006043: UF-L33 Electrodes (2 pk)
• 00851708006036: UF-L32 Electrode (2 pk)
• 00851708006029: UF-L31 Electrode (2 pk)
• 00851708006012: UF-L26 Electrode (2 pk)
• 00851708006005: UF-F12 Electrode (2 pk)
• 00851683006991: UF-L25 Electrode (2 pk)
• 00851683006984: UF-L24 Electrode (2 pk)
• 00851683006977: UF-L41 Electrode (2 pk)
• 00851683006960: UF-L39 Electrode (2 pk)
• 00851683006953: UF-L38 Electrodes (2 pk)
• 00851683006946: UF-L29 Electrode (2 pk)
• 00851683006939: UF-L23 Electrode (2 pk)
• 00851683006922: UF-L22 Electrode (2 pk)
• 00851683006915: UF-L21 Electrode (2 pk)
• 00851683006908: UF-L19 Electrode (2 pk)
• 00851683006892: UF-L18 Electrode (2 pk)
• 00851683006885: UF-L17 Electrode (2 pk)
• 00851683006878: UF-L16 Electrode (2 pk)
• 00851683006861: UF-F13 Electrode (2 pk)
• 00851683006854: UF-F11 Electrode (2 pk)
• 00851683006847: UF-F10 Electrode (2 pk)
• 00851683006830: UF-F1 Electrode (2 pk)
• 00851683006823: UF-C55 Electrode (2 pk)
• 00851683006816: UF-C54 Electrode (2 pk)
• 00851683006809: UF-C53 Electrode (2 pk)
• 00851683006793: UF-C52 Electrode (2 pk)
• 00851683006786: UF-C51 Electrode (2 Pk)
• 00851683006779: UF-C15 Electrode (2 pk)
• 00851683006762: RRSSD-8 Electrode set (8 pk)
• 00851683006755: RRSSD-6 Electrode set (6 pk)
• 00851683006748: R-L40 electrode (2 pk)
• 00851683006731: R-L30 Electrode (2 pk)