H200 Wireless

Basic Information

• Brand Name: H200 Wireless
• Primary DI: 00815962020290
• Version / Model: H2W-SW01
• Company Name: BIONESS INC.
• Labeler DUNS: 182287727
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-08
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 0e630231-8dbb-4e6c-8611-eb054d1b3f45

Device Description

Clinician Programmer Software

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: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
GZI	STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL	Neurology	882.5810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41457	Hand orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus intended to be used to encompass the whole or part of the hand to support, align, prevent, or correct deformities/injuries or to improve function of the hand. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815962020290	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius