Vilex Fibula Tool ZF-REAM-DIST

GUDID 00841731122018

Reamer, Fibula Distal 6.2mm Cann QC

VILEX IN TENNESSEE, INC.

Bone-resection orthopaedic reamer, reusable

Primary Device ID	00841731122018
NIH Device Record Key	d4db19bb-ffcf-4491-a958-fd7ae652ed52
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vilex Fibula Tool
Version Model Number	ZF-REAM-DIST
Catalog Number	ZF-REAM-DIST
Company DUNS	152008371
Company Name	VILEX IN TENNESSEE, INC.
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841731122018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151456

FDA Product Code

HSB	Rod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00841731122018]

Moist Heat or Steam Sterilization

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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

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

[00841731122018]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-09-14
Device Publish Date	2018-08-14

On-Brand Devices [Vilex Fibula Tool]

00841731122032	Driver, Fibula T10 Long
00841731122025	Reamer, Fibula Proximal 3.4mm Cann QC
00841731122018	Reamer, Fibula Distal 6.2mm Cann QC
00841731121981	Drill Sleeve, Fibula Nail, 2.5mm
00841731121974	Drill Sleeve, Fibula Nail, 2.0mm
00841731121967	Sleeve, Targeting, Fibula 3.5mm Nail
00841731121950	Sleeve, Targeting, Fibula 2.7mm Nail
00841731123299	Targeting, Fibula Nail, Long Screw
00841731123282	Targeting, Fibula Nail, Short Screw

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