URCHIN™

Basic Information

• Brand Name: URCHIN™
• Primary DI: 00643169669024
• Version / Model: 29700
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-08
• Public Version: 3
• Public Version Date: 2023-08-04
• Public Version Status: Update
• Public Device Record Key: e3a49cc0-f94a-48f8-9109-40e0f4350c56
• Distribution End Date: 2023-01-09

Device Description

HEART POSITIONER 29700 URCHIN 15L

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWS	stabilizer,heart	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15325	Patient positioning vacuum pad	A device designed to position and immobilize parts of the patient (e.g., head, extremities) typically during therapeutic interventions or patient transportation. The device immobilizes a body part by encompassing it and then applying a vacuum. The device is typically an airtight soft pillow case type of covering made of flexible materials, e.g., plastic or rubber. When sealed, this device retains the shape of the part that it encompasses until the vacuum is released.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169669024	GS1

Customer Contacts

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