TetraGraph Xcom

Basic Information

• Brand Name: TetraGraph Xcom
• Primary DI: 07350012440145
• Version / Model: SEN 2010 TetraGraph Xcom
• Catalog Number: SEN 2010
• Company Name: Senzime AB (Publ.)
• Labeler DUNS: 559976316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-07
• Public Version: 3
• Public Version Date: 2023-09-25
• Public Version Status: Update
• Public Device Record Key: 1bd4a9ad-8017-4eca-b5ba-8fd465eb4db1

Device Description

TetraGraph Xcom (Optional to use with TetraGraph)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	868.2775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35722	Block-monitoring peripheral nerve electrical stimulation system	An assembly of battery-powered devices designed to apply electrical stimuli to a peripheral nerve (e.g., the ulnar or lower extremity nerve) to assess the adequacy of neuromuscular block during surgery, and its reversal during the recovery period. The system typically uses four kinds of stimulation: twitch, train-of-four, tetanic, and double burst. It typically includes conventional electrocardiographic electrodes and/or bipolar surface electrodes (ball electrodes), and a pulse generator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350012440145	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]