ValuTrus

Basic Information

• Brand Name: ValuTrus
• Primary DI: 20705036013911
• Version / Model: ADPH
• Catalog Number: ADPH
• Company Name: ETHICON ENDO-SURGERY, LLC
• Labeler DUNS: 044606982
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-24
• Public Version: 3
• Public Version Date: 2021-08-06
• Public Version Status: Update
• Public Device Record Key: 65c2e298-92f1-4232-aa0b-aa76057a8b41
• Distribution End Date: 2021-08-05

Device Description

ValuTrus Reusable PPH Circular Stapler Handle

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDW	STAPLE, IMPLANTABLE	General, Plastic Surgery	878.4750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61623	Haemorrhoidal surgical stapler, reusable	A surgical instrument designed to apply surgical staples to tissue in the anal canal to treat haemorrhoids, particularly the procedure for prolapse and haemorrhoids (PPH) [repositioning of the anal canal mucosa to reduce blood flow to internal haemorrhoids]. It is typically pistol-like in design with a rounded, cylindrical head loaded with staples at the distal end, and operating levers at the proximal end intended to deliver a circular band(s) of staples, whilst cutting away hemorrhoidal tissue. It may include disposable supportive devices intended to assist the procedure (e.g., rectal dilator, anoscope). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	10705036013914	GS1
Package	30705036013918	GS1	CASE	10	Not in Commercial Distribution	2021-08-05
Primary	20705036013911	GS1

Customer Contacts

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