OsteoMed

Basic Information

• Brand Name: OsteoMed
• Primary DI: 00845694007986
• Version / Model: 254-2004-SP
• Catalog Number: 254-2004-SP
• Company Name: OSTEOMED LLC
• Labeler DUNS: 606417780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-24
• Public Version: 5
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: e0dd7737-2d37-4e91-990c-f3dedfd1f7a0

Device Description

2.0mm x 4mm Resorbable Screw, 4 Pack

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: No
• 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
DZL	SCREW, FIXATION, INTRAOSSEOUS	Dental	872.4880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46637	Craniofacial bone screw, bioabsorbable	A small, threaded rod with a slotted head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845694007986	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	4	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 120 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Care should be taken to keep resorbable plates and screws out of direct sunlight, moisture and excessive heat (greater than 120 DegreeF (45 DegreeC)) while packaged.