Scanlan® TIP-GUARD™ instrument protectors - Vented

Basic Information

• Brand Name: Scanlan® TIP-GUARD™ instrument protectors - Vented
• Primary DI: 00846159002188
• Version / Model: 1001-405
• Catalog Number: 1001-405
• Company Name: SCANLAN INTERNATIONAL INC
• Labeler DUNS: 023055619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-13
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 057fcf81-73d6-4158-baf5-1265a976ed5f

Device Description

Scanlan® TIP-GUARD™ instrument protectors - Vented - Tinted, Black Tinted, 3.2 x 25.4 x 25.4 mm (100 pieces per package)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34004	Surgical instrument guard, reusable	A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846159002188	GS1

Customer Contacts

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