N/A

GUDID 00763000034078

ELECTRODE 8227421 TWIST PAIR ST 4CH ROHS

MEDTRONIC XOMED, INC.

Subdermal needle electrode

• Primary Device ID: 00763000034078
• NIH Device Record Key: 2381eb73-a714-4b81-892f-efd239ad8021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 8227421
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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: true
• 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: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000034078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024316

FDA Product Code

• IKN: Electromyograph, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-27
• Device Publish Date: 2019-05-17

On-Brand Devices [N/A]

• 20613994839637: INSTRUMENT WIPE 2218525 25PK 9CM X 9CM
• 00613994513953: PROBE 945CNP2002 100MM CONCENTRIC
• 00613994370075: BUR 31113065 3MM CRS DIAMOND MED LENGTH
• 00613994370068: BUR 31112565 2.5MM CRS DIAMD MED LENGTH
• 00613994370051: BUR 31112065 2MM CRS DIAMOND MED LENGTH
• 00613994370020: BUR 31133065 3MM FINE DIAMOND MED LENGTH
• 00613994370013: BUR 31132565 2.5MM FINE DIAMD MED LENGTH
• 00613994370006: BUR 31132065 2MM FINE DIAMD MED LENGTH
• 00613994369994: BUR 31131565 1.5MM FINE DIAMD MED LENGTH
• 00613994369987: BUR 31131066 1MM FINE DIAMD MED LENGTH
• 00613994369970: BUR 31130566 .5MM FINE DIAMD MED LENGTH
• 00613994369963: BUR 31313065UE ULTRA 3MM STEEL MED LGTH
• 00613994369956: BUR 31312565UE ULTRA 2.5MM STL MED LGTH
• 00613994369949: BUR 31312065 2MM STEEL MED LENGTH
• 00613994369932: BUR 31311565 1.5MM STEEL MED LENGTH
• 00613994369925: BUR 31311066 1MM STEEL MED LENGTH
• 00613994353184: BUR 31133565 3.5MM FINE DIAMD MED LENGTH
• 00613994353122: BUR 31113565 3.5MM CRS DIAMD MED LENGTH
• 00613994353023: BUR 31313565UE ULTRA 3.5MM STEEL MED L
• 00613994353016: BUR 31311075 1MM STEEL X-LONG
• 00613994353009: BUR 31311575 1.5MM STEEL X-LONG
• 00613994352996: BUR 31312075 2MM STEEL X-LONG
• 00613994352989: BUR 31312575 2.5MM STEEL X-LONG
• 00613994352972: BUR 31313075UE ULTRA 3MM STEEL X-LONG
• 00613994352965: BUR 31313575UE ULTRA 3.5MM STEEL X-LONG
• 00613994352958: BUR 31314075UE ULTRA 4MM STEEL X-LONG
• 20613994233329: BLADE 1884080HR 5PK TRICUT M4 13CM 4MM
• 00613994233233: BUR 1885078HSE 13CM X 5MM 70DEG DIAMOND
• 00613994233219: BUR 1883277HSE 15CM X 3.2MM 40DG DIAMOND
• 00613994233196: BUR 1885076HSE 15CM X 5MM 15DEG DIAMOND
• 00613994233189: BUR 1884075HSE 15CM X 4MM 15DEG CUTTING
• 00613994233165: BUR 1883274HSE 15CM X 3.2MM 15DG DIAMOND
• 00613994221476: BUR 31236058 6MM SST PEAR MED LENGTH
• 00613994221469: BUR 31255558 5.5MM SST OVAL MED LENGTH
• 00613994221421: BUR 31134065 4MM FINE DIAMOND MED LENGTH
• 00613994221414: BUR 31135059 5MM FINE DIAMOND MED LENGTH
• 00613994221407: BUR 31136058 6MM FINE DIAMOND MED LENGTH
• 00613994221391: BUR 31114065 4MM CRSE DIAMOND MED LENGTH
• 00613994221377: BUR 31115059 5MM CRSE DIAMOND MED LENGTH
• 00613994221360: BUR 31116058 6MM CRSE DIAMOND MED LENGTH
• 00613994102232: BUR 31314065UE ULTRA 4MM MED LENGTH
• 20613994102229: BUR 31314065U ULTRA 5PK 4MM MED LENGTH
• 00613994102218: BUR 31315059UE ULTRA 5MM MED LENGTH
• 20613994102205: BUR 31315059U ULTRA 5PK 5MM MED LENGTH
• 00613994102188: BUR 31316058UE ULTRA 6MM MED LENGTH
• 20613994102175: BUR 31316058U ULTRA 5PK 6MM MED LENGTH
• 00613994102164: BUR 31317057UE ULTRA 7MM MED LENGTH
• 20613994102151: BUR 31317057U ULTRA 5PK 7MM MED LENGTH
• 00613994097170: BUR 31135051 5MM FINE DIAMOND STD LENGTH
• 00643169938847: ELECTRODE 8227703 PRD NDL 22MM 8CH ROHS