OsteoMed

Basic Information

• Brand Name: OsteoMed
• Primary DI: 00845694094153
• Version / Model: 320-2708
• Catalog Number: 320-2708
• Company Name: OSTEOMED LLC
• Labeler DUNS: 606417780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-09
• Public Version: 3
• Public Version Date: 2020-01-28
• Public Version Status: Update
• Public Device Record Key: 925ba43f-fd81-4ba2-8126-9f1808508b1a

Device Description

Screwdrivers Shaft, T8

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
HRS	Plate, fixation, bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47633	Surgical screwdriver, single-use, non-sterile	A non-sterile, non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845694094153	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	91	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Stored at controlled room temperature away from moisture and direct sunlight