Rolled Probe Cover and Rubber Bands

Basic Information

• Brand Name: Rolled Probe Cover and Rubber Bands
• Primary DI: 20841912100891
• Version / Model: 3248
• Catalog Number: VPC0108NS
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• Labeler DUNS: 965417181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-10-25
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6807bf58-9148-4244-83ff-1d9e2c7371b9

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60609	Body-orifice ultrasound imaging transducer cover, basic, non-sterile	A non-sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20841912100891	GS1
Unit of Use	00841912100897	GS1

Premarket Submissions

Submission Number	Supplement Number
K970891	000