PIPELINE

Basic Information

• Brand Name: PIPELINE
• Primary DI: 10705034221069
• Version / Model: 288226140
• Catalog Number: 288226140
• Company Name: DEPUY SPINE, LLC
• Labeler DUNS: 107105876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 8
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: fe3d238e-5457-4102-b81c-c6e4cd09b3fd

Device Description

PIPELINE ACCESS SYSTEM ANGLED RETRACTION PORT 26 x 40mm

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: No
• 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
GZT	RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY	Neurology	882.4800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47821	Surgical retractor/retraction system blade, single-use	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10705034221069	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992898	000