DISTRACTION, INTERNAL

Basic Information

• Brand Name: DISTRACTION, INTERNAL
• Primary DI: 00888118081872
• Version / Model: 51-525-90-07
• Company Name: KLS-Martin L.P.
• Labeler DUNS: 826499238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-26
• Public Version: 4
• Public Version Date: 2020-02-14
• Public Version Status: Update
• Public Device Record Key: 7db5f40e-d743-4959-be93-61873f0cf9bd

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HXX	SCREWDRIVER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64610	Implantable craniofacial bone distractor expansion tool, home-use	A hand-held, manual device intended to be used by a layperson to adjust an intraoral implantable craniofacial bone distractor to progressively lengthen the distractor, typically during expansion of the maxilla. It is used by the patient in the home for daily, gradual distraction. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888118081872	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]