Sheathes

Basic Information

• Brand Name: Sheathes
• Primary DI: 10842418100203
• Version / Model: 10740
• Company Name: SHEATHING TECHNOLOGIES, INC.
• Labeler DUNS: 806806220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 5
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: c5bcaf85-e557-4b5f-b50e-2c6bd6a0dd06

Device Description

Latex, 1"D x 8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Improved Narrow, Rolled

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: 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
60608	Body-orifice ultrasound imaging transducer cover, basic	A 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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20842418100200	GS1	CASE	6	In Commercial Distribution
Primary	10842418100203	GS1
Unit of Use	00842418100206	GS1

Premarket Submissions

Submission Number	Supplement Number
K925869	000