Sheathes

Basic Information

• Brand Name: Sheathes
• Primary DI: 10842418104096
• Version / Model: 5-26840-PT
• Company Name: SHEATHING TECHNOLOGIES, INC.
• Labeler DUNS: 806806220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2018-08-28
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 0bafd310-0408-4c51-afb6-2298626c66f5

Device Description

Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rectal, Tapered, Un-Rolled with Pull Tab, Extra-Long

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
OIP	Radiology-Diagnostic Kit	Radiology	892.1680	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
58735	Topical coupling gel, sterile	A sterile medium designed to be applied to a patient's skin surface to provide a coupling between an ultrasound transducer and the patient, allowing for the emission and reception of ultrasonic waves that pass through the skin during an ultrasound examination requiring sterile procedure. It is in the form of a non-sticky, drip resistant, fluid-like gel that has been thermally sterilized (contains no degradation products of radiation sterilization) that also assists the operator's ability to move the ultrasound transducer (probe) smoothly over the skin to better scan the site of interest. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20842418104093	GS1	CASE	3	In Commercial Distribution
Primary	10842418104096	GS1
Unit of Use	00842418104099	GS1