STRAIGHTSHOT

Basic Information

• Brand Name: STRAIGHTSHOT
• Primary DI: 10886705011056
• Version / Model: 232220
• Catalog Number: 232220
• Company Name: DEPUY MITEK, LLC
• Labeler DUNS: 190572854
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 7
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: e6ef94a5-8f76-4f7b-84c5-01918eb521d9

Device Description

STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 11.5mm

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
JDW	PIN, FIXATION, THREADED	Orthopedic	888.3040	2
HWC	Screw, fixation, bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62729	Orthopaedic guidewire, single-use	A thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886705011053	GS1	PACKAGE	10	In Commercial Distribution
Primary	10886705011056	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K934366	000