Tenolok

Basic Information

• Brand Name: Tenolok
• Primary DI: 30845854044678
• Version / Model: T50S70
• Catalog Number: T50S70
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-11
• Public Version: 1
• Public Version Date: 2021-02-19
• Public Version Status: New
• Public Device Record Key: 77211b54-9bd8-4ea4-8def-c2c9a8febd2a

Device Description

Tenolok Tenodesis Kit With 5.0mm Tenolok Anchor with One #2 Hi-Fi Suture, 2.4mm Guide Pin, And 7.0mm Drill Bit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MBI	Fastener, fixation, nondegradable, soft tissue	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44093	Arthroscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30845854044678	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120841	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY