CANNULA Ø2.49/1.61MM L250MM ROSAS00119

GUDID 03760244030412

CANNULA Ø2.49/1.61MM L250MM instrument Rosa one (spine application) Reducing tube for implantation of guidewires

MEDTECH

Multi-purpose stereotactic surgery system

Primary Device ID	03760244030412
NIH Device Record Key	18825866-9a4c-45af-b4d4-13f40defe7ea
Commercial Distribution Status	In Commercial Distribution
Brand Name	CANNULA Ø2.49/1.61MM L250MM
Version Model Number	MALI-133B
Catalog Number	ROSAS00119
Company DUNS	264502977
Company Name	MEDTECH
Device Count	2
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760244030412 [Primary]
GS1	03760244033000 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182848

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

[03760244030412]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-12-20
Device Publish Date	2019-12-09

On-Brand Devices [CANNULA Ø2.49/1.61MM L250MM]

03760244030412	CANNULA Ø2.49/1.61MM L250MM instrument Rosa one (spine application) Reducing tube for implantat
03760244031518	CANNULA Ø2.49/1.61MM L250MM instrument Rosa one 3.1 (spine application) Reducing tube for impla

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.