301019028

GUDID 10705034561264

NAVIGATION ENABLED INSTRUMENTS STANDARD THREAD TAP 3.0MM

Medos International Sàrl

Bone tap, reusable

Primary Device ID	10705034561264
NIH Device Record Key	db023a8b-0a40-42b6-8303-236602cbb50a
Commercial Distribution Status	In Commercial Distribution
Version Model Number	3010-19-028
Catalog Number	301019028
Company DUNS	482661753
Company Name	Medos International Sàrl
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
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

Customer Support Contacts

Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034561264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K200791

FDA Product Code

OLO	Orthopedic stereotaxic instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

[10705034561264]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-05-03
Device Publish Date	2021-04-24

Devices Manufactured by Medos International Sàrl

10705034062358 - MONARCH	2024-07-29 MONARCH SPINE SYSTEM S/C WITH WASHER, STRAIGHT 5.5mm
10705034062365 - MONARCH	2024-07-29 MONARCH SPINE SYSTEM S/C WITH WASHER, EXT 5.5mm
10705034062372 - MONARCH	2024-07-29 MONARCH SPINE SYSTEM SLOTTED CONNECTOR WITH WASHER, OFFSET, RIGHT 5.5mm
10705034062396 - MONARCH	2024-07-29 MONARCH SPINE SYSTEM SLOTTED CONNECTOR WITH WASHER, OFFSET, LEFT 5.5mm
10705034584881 - TRIALTIS	2024-07-26 TRIALTIS Spine System Polyaxial Favored Angle Screw Fenestrated ø10mm x 60mm 5.5 and 6.0
10705034032108 - EXPEDIUM	2024-07-24 EXPEDIUM SPINE SYSTEM SPINAL WIRE WITH BUTTON Diameter 1.0mm
10705034032115 - EXPEDIUM	2024-07-24 EXPEDIUM SPINE SYSTEM SPINAL WIRE, DOUBLE Diameter 1.0mm
10705034032122 - EXPEDIUM	2024-07-24 EXPEDIUM SPINE SYSTEM SPINAL WIRE, SINGLE Diameter 1.0mm

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