WALTERLORENZ™ SURGICAL ASSIST ARM

Basic Information

• Brand Name: WALTERLORENZ™ SURGICAL ASSIST ARM
• Primary DI: 00841036240448
• Version / Model: WAL305
• Catalog Number: WAL305
• Company Name: BIOMET MICROFIXATION, INC
• Labeler DUNS: 046189866
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-17
• Public Version: 1
• Public Version Date: 2019-06-25
• Public Version Status: New
• Public Device Record Key: b29e85c4-0244-4030-8720-b87d87174e30

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: No
• 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
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2
OCV	Endoscope holder	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32288	Surgical camera holder	A device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841036240448	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190576	000