DRILL GUIDE Ø4MM ROSAS00157

GUDID 03760244030634

CANNULA Ø4MM instrument Rosa one (spine application) Cannula for guidance of reducing tubes

MEDTECH

Multi-purpose stereotactic surgery system

Primary Device ID	03760244030634
NIH Device Record Key	26192fb2-7c22-4df1-bcf4-294136bb79b6
Commercial Distribution Status	In Commercial Distribution
Brand Name	DRILL GUIDE Ø4MM
Version Model Number	ROSA3-131A
Catalog Number	ROSAS00157
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	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	03760244030634 [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

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

Moist Heat or Steam Sterilization

[03760244030634]

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	2019-11-18

On-Brand Devices [DRILL GUIDE Ø4MM]

03760244030634	CANNULA Ø4MM instrument Rosa one (spine application) Cannula for guidance of reducing tubes
03760244033635	"CANNULA Ø4MM (DRILL GUIDE) instrument Rosa one 3.1 (spine application) Cannula for guidance of
03760244031334	CANNULA Ø4MM (DRILL GUIDE) instrument Rosa one 3.1 (spine application) Cannula for guidance of

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