5.0 X 120MM OUTER SLEEVE

Basic Information

• Brand Name: 5.0 X 120MM OUTER SLEEVE
• Primary DI: 00816950029790
• Version / Model: 303-5006
• Catalog Number: 303-5006
• Company Name: Osteocentric Technologies, Inc.
• Labeler DUNS: 089645059
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-16
• Public Version: 2
• Public Version Date: 2023-08-16
• Public Version Status: Update
• Public Device Record Key: 716f0cc1-f995-4164-a2bf-8a0957b18f2f

Device Description

5.0 X 120MM OUTER SLEEVE

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63105	Orthopaedic instrument extractor	A hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816950029790	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5.0	Millimeter
Length	120	Millimeter