Anterior Disc Prep

Basic Information

• Brand Name: Anterior Disc Prep
• Primary DI: 10889981189334
• Version / Model: 95-6193
• Catalog Number: 95-6193
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Labeler DUNS: 079840876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-27
• Public Version: 1
• Public Version Date: 2020-04-06
• Public Version Status: New
• Public Device Record Key: b0da9382-8599-46b4-9566-32dda5365185

Device Description

ALIF Modular Distractor Tip - 9mm

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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56639	Collection syringe adaptor, single-use	A small sterile device designed be placed over the top of a syringe to encase the tip of the syringe as means to modify the shape and the size of the syringe tip. It is typically made of polymer material and its shape and size mimics that of the appropriately-matched syringe barrel (i.e., 60 cc, 30 cc, 10 cc versions of a Toomey style syringe). It is typically used for the transfer of human tissue or other substances from one container to another during plastic and reconstructive surgery, cosmetic surgery, or general surgery procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889981189334	GS1

Customer Contacts

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