DISTRACTION, INTERNAL

Basic Information

• Brand Name: DISTRACTION, INTERNAL
• Primary DI: 00888118136596
• Version / Model: 25-025-43-07
• Company Name: KLS-Martin L.P.
• Labeler DUNS: 826499238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-25
• Public Version: 1
• Public Version Date: 2024-01-02
• Public Version Status: New
• Public Device Record Key: 86ccbdd3-6411-43cd-ae0d-f87753e78eff

Device Description

INSERTER, SPRING, CRANIOXPAND, BACKWARD OPENING

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: No
• 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
PBJ	Cranial Distraction System	Neurology	882.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46751	Bone holding forceps	A manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888118136596	GS1

Customer Contacts

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