Twisted Pair Needle Electrode 003-400124-3

GUDID 00852373007083

Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired electrodes packaged individual, inside one package, to preserve sterility of the product. Used as a set for one medical operation.

SGM d.o.o.

Electromyographic needle electrode, single-use

• Primary Device ID: 00852373007083
• NIH Device Record Key: a42e6315-0d7b-4d30-9739-2b8e40a37f7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twisted Pair Needle Electrode
• Version Model Number: 003-400124-3
• Catalog Number: 003-400124-3
• Company DUNS: 499490357
• Company Name: SGM d.o.o.
• Device Count: 3
• 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: true
• 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: 4049445709
• Email: suzy.simic@medical-electrodes.com

Device Dimensions

• Length: 2 Meter
• Length: 2 Meter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852373007076 [Unit of Use]
GS1	00852373007083 [Primary]
GS1	00852373007090 [Package]; Package: Carton Box [250 Units]; In Commercial Distribution
GS1	00852373007144 [Package]; Package: Carton Box [350 Units]; In Commercial Distribution
GS1	00852373007151 [Package]; Package: Carton Box [100 Units]; In Commercial Distribution
GS1	00852373007175 [Package]; Package: Carton Box [300 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010019

FDA Product Code

• IKT: Electrode, Needle, Diagnostic Electromyograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by SGM d.o.o.

• 00852373007212 - Corkscrew Electrode: 2018-08-09 Corkscrew electrode CS-F (2m) 003-400001-5. Five twisted electrodes in double package to preserve sterility of the product. Use
• 00852373007243 - Corkscew Electrode: 2018-08-09 Corkscrew electrode CS-F (2m) 003-400001-4. Four twisted electrodes in double package to preserve sterility of the product. Use
• 00852373007021 - Corkscrew Electrode: 2018-07-06 Corkscrew Electrode CS-F (1,0m) 003-400000-6. Six packed individual inside one package to preserve sterility of the product. Us
• 00852373007052 - Corkscrew Electrode: 2018-07-06 Corkscrew Electrode CS-F (1,5m) 003-400001-6. Six packed individual inside one package of 6 to preserve sterility of the produ
• 00852373007083 - Twisted Pair Needle Electrode: 2018-07-06Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired electrodes packaged individual, inside one package, to preserve sterility of the product. Used as a set for one medical operation.
• 00852373007083 - Twisted Pair Needle Electrode: 2018-07-06 Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired electrodes packaged individual, inside on