OsteoMed

Basic Information

• Brand Name: OsteoMed
• Primary DI: 00845694035842
• Version / Model: 316-0046
• Catalog Number: 316-0046
• Company Name: OSTEOMED LLC
• Labeler DUNS: 606417780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-22
• Public Version: 3
• Public Version Date: 2020-01-28
• Public Version Status: Update
• Public Device Record Key: 94fb46f5-eb3e-4f00-9107-c76c6daee0f1

Device Description

Bone Clamp, Curved Lobster Claw

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: Yes
• 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
HWC	Screw, fixation, bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35595	Bone clamp traction bar	A manual surgical device designed to bridge two opposing bone clamps being used as a pair, one on either side of a fracture (the proximal and distal segment of a fractured bone) that is being approximated during orthopaedic surgery. It is attached to the stem of each of the bone clamps and using its screw mechanism, the fracture is drawn together by the surgeon. It is typically made of high-grade stainless steel and is designed for this function only. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845694035842	GS1

Customer Contacts

• Phone: [phone] ext. 1
• Email: [email protected]