Pivot Guardian

Basic Information

• Brand Name: Pivot Guardian
• Primary DI: 07613327380378
• Version / Model: 3105000950
• Catalog Number: 3105-000-950
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 187502109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-19
• Public Version: 3
• Public Version Date: 2020-03-23
• Public Version Status: Update
• Public Device Record Key: 3abfe3f3-b2a0-4b33-87e3-95ed4fc3fc28

Device Description

PostFree Perineal Accessory Kit

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HST	Apparatus, traction, non-powered	Orthopedic	888.5850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41675	Surgical counter-traction post	A cylindrical rod designed to be attached to an operating table or extension device to function as a support to counter the pulling of the traction being applied to a patient's body part (e.g., leg, pelvis) during an orthopaedic surgical procedure (e.g., hip arthroplasty, pelvic reconstruction); it is typically placed against the perineal region [referred to as perineal post] or leg bones (e.g., femur, tibia). It is available in various diameters and lengths and is typically padded. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327380378	GS1

Customer Contacts

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