WeL® ORTHO-SUCTION TUBE

Basic Information

• Brand Name: WeL® ORTHO-SUCTION TUBE
• Primary DI: M7245091ST1
• Version / Model: 5091, Sterile
• Catalog Number: 5091-ST
• Company Name: IMPLANTECH ASSOCIATES, INC.
• Labeler DUNS: 784664955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-29
• Public Version: 2
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 4e7402f5-7fdd-4bf4-a212-3e4ca0a630e2

Device Description

WeL® Bullet-Nosed Tip

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOL	Catheter And Tip, Suction	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34923	Suction system catheter, general-purpose	A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7245091ST1	HIBCC
Package	M7245091ST2	HIBCC	Box	50	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]