BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

LEOS Cannulated Screw System

DI: 00196449024056 · Model: 76308853 · Tyber Medical, LLC

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: LEOS Cannulated Screw System
Primary DI: 00196449024056
Version / Model: 76308853
Catalog Number: 76308853
Company Name: Tyber Medical, LLC
Labeler DUNS: 010968002
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-03-31
Public Version: 2
Public Version Date: 2025-08-15
Public Version Status: Update
Public Device Record Key: 7e58c3c3-e3b2-49c0-a90a-c81cc3fa6fd4

Device Description

3.0 X 229mm Drill Large AO

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: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTW	BIT, DRILL	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61235	Cannulated surgical drill bit, single-use	A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00196449024056	GS1

Customer Contacts

Phone: +1(866)761-0933 ext. 444
Email: [email protected]