OsteoMed

Basic Information

• Brand Name: OsteoMed
• Primary DI: 00845694073080
• Version / Model: 320-0409-SP-02
• Catalog Number: 320-0409-SP-02
• Company Name: OSTEOMED LLC
• Labeler DUNS: 606417780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-28
• Public Version: 3
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 1a5542fd-1bec-42da-86b7-5c455cd1ad24

Device Description

FPS .213 x 9" Partially Threaded Steinman Pin Sterile Qty 2

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HXK	HOLDER, NEEDLE; ORTHOPEDIC	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32854	Orthopaedic bone pin, non-bioabsorbable	A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845694073080	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5.4	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Stored at controlled room temperature