SCANLAN® Pincap® orthopedic pin protectors

Basic Information

• Brand Name: SCANLAN® Pincap® orthopedic pin protectors
• Primary DI: 00846159028713
• Version / Model: 301-0110B
• Catalog Number: 301-0110B
• Company Name: SCANLAN INTERNATIONAL INC
• Labeler DUNS: 023055619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-28
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8f08cca5-838c-44d8-8f62-4404df280010

Device Description

SCANLAN® Pincap® orthopedic pin protectors - White, fits 3 pin/wire sizes: 0.71, 0.89, 1.14 mm, BNS (40 per bag)

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35257	Vascular booties	A sterile cover, used in pairs, fitted onto the distal working end (the jaws) of artery forceps, vascular clamps, or similar surgical instruments, to provide improved grip for delicate sutures. It is typically tube-like with a closed, rounded tip and composed of radiopaque silicone materials. It is available in various sizes and may be straight or curved. The pair of devices may also be known as "jaw covers" (shods). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846159028713	GS1

Customer Contacts

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