Surgi-Tip Transducer Cover

Basic Information

• Brand Name: Surgi-Tip Transducer Cover
• Primary DI: 10841436110362
• Version / Model: UA0074
• Catalog Number: UA0074
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Labeler DUNS: 134614411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-22
• Public Version: 5
• Public Version Date: 2021-09-06
• Public Version Status: Update
• Public Device Record Key: ba6d8b9d-088c-47f3-9908-eb9114090691

Device Description

Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard™ tip for use with BK Medical 10L2w, 13L4w, 14L3, 18L5, 8670, 8811, 8812, 8814, 8822 and 8870 transducers

Device Characteristics

• Single Use: Yes
• 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: 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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44714	Intraoperative ultrasound imaging transducer cover	A sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00841436110365	GS1		12	In Commercial Distribution
Primary	10841436110362	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013721	000

Device Sizes

Type	Value	Unit	Text
Length	244	Centimeter
Width	20.3	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight
• Type: Storage Environment Temperature
• Temperature Range: 52 – 85 Degrees Fahrenheit