3D X-RAY PATTERN ROSAS00128

GUDID 03760244030443

3D X-RAY PATTERN instrument Rosa one (spine application) Calibrated device to register intraoperative 3D exams

MEDTECH

Multi-purpose stereotactic surgery system

Primary Device ID	03760244030443
NIH Device Record Key	0ff274c9-4419-448c-b55f-5d218b136f60
Commercial Distribution Status	In Commercial Distribution
Brand Name	3D X-RAY PATTERN
Version Model Number	ROSA3-144B
Catalog Number	ROSAS00128
Company DUNS	264502977
Company Name	MEDTECH
Device Count	1
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	false
Lot Batch	false
Serial Number	true
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	03760244030443 [Primary]

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

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

Moist Heat or Steam Sterilization

[03760244030443]

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 [3D X-RAY PATTERN]

03760244030443	3D X-RAY PATTERN instrument Rosa one (spine application) Calibrated device to register intraoper
03760244031785	3D X-RAY PATTERN instrument Rosa one 3.1 (spine application) Calibrated device to register intra
03760244033383	3D X-RAY PATTERN instrument Rosa one 3.1 (spine application) Calibrated device to register intra

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