CASE

Basic Information

• Brand Name: CASE
• Primary DI: 00702173355696
• Version / Model: IV
• Company Name: WR MEDICAL ELECTRONICS CO INC
• Labeler DUNS: 006196604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-29
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4174aac8-2e5a-4bfa-9106-18981c9fec66

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: 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
LLN	Device, Vibration Threshold Measurement	Neurology	882.1200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37349	Vibratory biothesiometer	An electronic instrument intended to produce vibrations that are applied to a part of the body (often the great toe) in a range of intensities to noninvasively measure vibratory sensation threshold. Sometimes referred to as a vibrameter, It is typically used for neuropathological diagnoses and evaluation of the neurological health effects of diabetes mellitus, exposure to neurotoxic compounds (e.g., solvents or heavy metals), poor ergonomic working conditions, chemotherapy or trauma.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00702173355696	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K910624	000