OsteoMed

Basic Information

• Brand Name: OsteoMed
• Primary DI: 00845694053617
• Version / Model: 218-3140-SP
• Catalog Number: 218-3140-SP
• Company Name: OSTEOMED LLC
• Labeler DUNS: 606417780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-21
• Public Version: 3
• Public Version Date: 2019-09-23
• Public Version Status: Update
• Public Device Record Key: 8d6662cf-6a4d-4516-be27-53b3ba19c40a

Device Description

CDS Spring NC – 4N

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: Yes
• 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
PBJ	Cranial Distraction System	Neurology	882.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47635	Implantable craniofacial bone distractor	An implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845694053617	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Force = 4.0 N

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at a controlled room temperature between 15ºC to 30ºC (59ºF to 86ºF).