SR PIP

Basic Information

• Brand Name: SR PIP
• Primary DI: 00886385020341
• Version / Model: SR PIP-4
• Company Name: Stryker Trauma SA
• Labeler DUNS: 481999654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-27
• Public Version: 3
• Public Version Date: 2022-05-13
• Public Version Status: Update
• Public Device Record Key: eefcaec6-1acc-49d5-b755-d5251cebd5b4

Device Description

Proximal Interphalangeal Implant, Size 4

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
MPK	Semi-Constrained Metal/Polymer Finger Joint Prosthesis	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
60459	Proximal interphalangeal joint prosthesis, modular	A sterile, implantable artificial substitute for the proximal interphalangeal (PIP) joint(s) of the hand (finger) which typically has been damaged by rheumatoid, degenerative, or traumatic arthritis. The device typically consists of proximal and distal metal (e.g., titanium) stems, which may be coated with a material (e.g., hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth, for insertion into the prepared phalanges of the joint. The stems may have articulating surfaces or there may be separate metal [e.g., cobalt-chrome (Co-Cr)] and/or plastic ( e.g., polyethylene) articulating surface components. Dedicated tools for implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886385020341	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid exposure to direct sunlight or dampness