Sheathes3D

Basic Information

• Brand Name: Sheathes3D
• Primary DI: 10842418102320
• Version / Model: 50040-IT964
• Company Name: SHEATHING TECHNOLOGIES, INC.
• Labeler DUNS: 806806220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-02-28
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4429b330-9102-46e8-8700-a4e34f686c23

Device Description

Seamless Viral Barrier Contour T-End, Latex-Free, 2.1" x 0.5" Face to 4"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Telescopically Folded

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
44713	Body-surface ultrasound imaging transducer cover	A device/material 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 system imaging transducer (probe) used on the body surface 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	20842418102327	GS1	CASE	3	In Commercial Distribution
Primary	10842418102320	GS1
Unit of Use	00842418102323	GS1

Premarket Submissions

Submission Number	Supplement Number
K153212	000