Reprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/Tubing

Basic Information

• Brand Name: Reprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/Tubing
• Primary DI: B3901912038T1
• Version / Model: 19-12038T
• Company Name: SURETEK MEDICAL
• Labeler DUNS: 785616934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-01
• Public Version: 1
• Public Version Date: 2025-05-09
• Public Version Status: New
• Public Device Record Key: 3eaf3681-3617-45de-892c-da0adedcd51f

Device Description

Reprocessed 4mm Endo-Scrub 2 Sheath, 0 deg, w/Tubing. Used with Olympus WA96200A

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
KAM	Cannula, Sinus	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44711	Optical medical device procedural cover	A device designed to fit over the distal end of a non-surgically-invasive device with optical functionality (e.g., laser beam-guide, optical scanning handpiece, endoscope) during use, to act as a cover/shield to avoid direct contact to the eye and/or cross-contamination between patients; it is not intended to act as a spacer. It is typically a small rigid partially- or fully- transparent plastic device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B3901912038T1	HIBCC