Sheathes

Basic Information

• Brand Name: Sheathes
• Primary DI: 30842418100474
• Version / Model: 26840 24/Bag
• Company Name: SHEATHING TECHNOLOGIES, INC.
• Labeler DUNS: 806806220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2018-01-03
• Public Version: 5
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 5453a89f-24cf-4bc8-80e1-91de2f70f677

Device Description

Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled with Pull Tab, 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: 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
Primary	30842418100474	GS1
Unit of Use	00842418100473	GS1

Premarket Submissions

Submission Number	Supplement Number
K990175	000