ValuTrus

Basic Information

• Brand Name: ValuTrus
• Primary DI: 20705036013980
• Version / Model: ADLH
• Catalog Number: ADLH
• 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: 62aa3de0-6f66-4bfb-a16a-551c454114ee
• Distribution End Date: 2021-08-05

Device Description

ValuTrus Reusable Linear Stapler Handle, Reusable

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
61624	Open-surgery manual linear cutting stapler, reusable	A hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. 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	10705036013983	GS1
Package	30705036013987	GS1	CASE	10	Not in Commercial Distribution	2021-08-05
Primary	20705036013980	GS1

Customer Contacts

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