AWL Ø4.0MM ROSAS00155

GUDID 03760244030610

AWL Ø4.0MM instrument Rosa one (spine application) Awl for soft tissues dilation

MEDTECH

Multi-purpose stereotactic surgery system

Primary Device ID	03760244030610
NIH Device Record Key	3f67ba23-e762-412a-9063-6316286def7e
Commercial Distribution Status	In Commercial Distribution
Brand Name	AWL Ø4.0MM
Version Model Number	ROSA3-122A
Catalog Number	ROSAS00155
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	03760244030610 [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

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

Moist Heat or Steam Sterilization

[03760244030610]

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 [AWL Ø4.0MM]

03760244030610	AWL Ø4.0MM instrument Rosa one (spine application) Awl for soft tissues dilation
03760244033604	"AWL Ø4.0MM instrument Rosa one 3.1 (spine application) Awl for soft tissues dilation "
03760244031136	AWL Ø4.0MM instrument Rosa one 3.1 (spine application) Awl for soft tissues dilation "

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