N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00763000191856
• Version / Model: TH90D01
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-04
• Public Version: 2
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: b2ac0c68-e5de-4082-8a27-854a4320be3b

Device Description

COMM HANDSET KIT TH90D01 DBS US

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
OLM	Deep brain stimulator for obsessive compulsive disorder (OCD)	Unknown		f
MRU	implanted subcortical electrical Stimulator (motor disorders)	Unknown		f
MBX	STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED	Unknown		3
PJS	Stimulator, electrical, implanted, for essential tremor	Unknown		3
MHY	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	Unknown		3
NHL	Stimulator, electrical, implanted, for parkinsonian symptoms	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61393	Multiple active implantable device programmer	An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000191856	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
H020007	231
H050003	200
P960009	333

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -31 – 136 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -35 – 58 Degrees Celsius