Non-Sterile Probe Storage Covers

Basic Information

• Brand Name: Non-Sterile Probe Storage Covers
• Primary DI: 30841912104261
• Version / Model: 1160
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• Labeler DUNS: 965417181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-10-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 12f08e22-414d-4437-94a4-85fc978d2387

Device Characteristics

• Single Use: Yes
• 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: 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
MMP	Cover, Barrier, Protective	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43970	Cable/lead/sensor/probe cover, sterile	A sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical field. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40841912104268	GS1		4	In Commercial Distribution
Primary	30841912104261	GS1
Unit of Use	00841912104260	GS1

Premarket Submissions

Submission Number	Supplement Number
K970889	000