SPIROFIT PINNACLE

Basic Information

• Brand Name: SPIROFIT PINNACLE
• Primary DI: 10603295079804
• Version / Model: 2000-50-056
• Catalog Number: 200050056
• Company Name: DEPUY (IRELAND)
• Labeler DUNS: 989365556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 2
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: 5930f485-f534-43c4-af09-e69820152160

Device Description

SPIROFIT PINNACLE SCREWING PLATE DIAMETER 56

Device Characteristics

• Single Use: No
• 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: No
• 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
HXO	PUSHER, SOCKET	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32878	Hip prosthesis socket pusher	A hand-held manual surgical instrument with a grip designed to hold an acetabular cup or shell at the distal end. It is rod-like in shape and used to force the acetabular component of a total hip prosthesis into the proper position in the acetabular vault of the pelvis. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295079804	GS1

Customer Contacts

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