T2 ALPHA

Basic Information

• Brand Name: T2 ALPHA
• Primary DI: 07613327365030
• Version / Model: 2341-0010S
• Catalog Number: 2341-0010S
• Company Name: Stryker Trauma SA
• Labeler DUNS: 481999654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-29
• Public Version: 3
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 5cd5b12e-b683-4360-b0f8-34b165a7ebe2

Device Description

End Cap Tibia

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: MR Conditional
• 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
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46139	Bone nail end-cap	A small, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327365030	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter: 11.5 Millimeter
Device Size Text, specify			Offset: 10.0 Millimeter