LONG UNIV HANDLE ADP ROSAS00177

GUDID 03760244031938

"LONG UNIVERSAL HANDLE ADAPTOR instrument Rosa one 3.1 (spine application) Adaptor for universal handle, long"

MEDTECH

Multi-purpose stereotactic surgery system

Primary Device ID	03760244031938
NIH Device Record Key	b9adab34-b162-4caa-8bab-ea94958e93a6
Commercial Distribution Status	In Commercial Distribution
Brand Name	LONG UNIV HANDLE ADP
Version Model Number	174034-00
Catalog Number	ROSAS00177
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	03760244031938 [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

[03760244031938]

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[03760244031938]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[03760244031938]

Moist Heat or Steam Sterilization

[03760244031938]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[03760244031938]

Moist Heat or Steam Sterilization

[03760244031938]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-12-17
Device Publish Date	2019-12-09

On-Brand Devices [LONG UNIV HANDLE ADP]

03760244031938	"LONG UNIVERSAL HANDLE ADAPTOR instrument Rosa one 3.1 (spine application) Adaptor for universal
03760244033529	"LONG UNIVERSAL HANDLE ADAPTOR instrument Rosa one 3.1 (spine application) Adaptor for universal

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