MICROTEK

Basic Information

• Brand Name: MICROTEK
• Primary DI: 00748426120956
• Version / Model: 1
• Company Name: Microtek Medical Inc.
• Labeler DUNS: 106908437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-27
• Public Version: 5
• Public Version Date: 2023-03-22
• Public Version Status: Update
• Public Device Record Key: 99e1c484-0a7b-4924-9235-77b9dab3cfee

Device Description

ROLLED PROBE COVER

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: 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
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
Package	50748426120951	GS1		2	In Commercial Distribution
Package	30748426120957	GS1		25	In Commercial Distribution
Primary	00748426120956	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K882724	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store under normal warehouse conditions.