Sheathes

Basic Information

• Brand Name: Sheathes
• Primary DI: 10842418104249
• Version / Model: 29320
• Company Name: SHEATHING TECHNOLOGIES, INC.
• Labeler DUNS: 806806220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 400
• Record Status: Published
• Publish Date: 2019-08-13
• Public Version: 1
• Public Version Date: 2019-08-21
• Public Version Status: New
• Public Device Record Key: 1e120714-3fe5-4fb2-834e-e50a3ce1e72d

Device Description

Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Bi-Directionally Rolled, Extra-Long

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: No
• 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
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	20842418104246	GS1	CASE	4	In Commercial Distribution
Primary	10842418104249	GS1
Unit of Use	00842418104242	GS1