UNiD MIS B33255522-01

GUDID 03613720286608

UNiD CoCr Percutaneous Rod Ø5.5mm-DEGEN

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	03613720286608
NIH Device Record Key	5d3dcaec-dc96-470d-927b-db91fdd2167e
Commercial Distribution Status	In Commercial Distribution
Brand Name	UNiD MIS
Version Model Number	B33255522-01
Catalog Number	B33255522-01
Company DUNS	383228632
Company Name	MEDICREA INTERNATIONAL
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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	03613720286608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K140738

FDA Product Code

MNI	Orthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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[03613720286608]

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Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-03-04
Device Publish Date	2021-02-24

On-Brand Devices [UNiD MIS]

03613720286660	UNiD CoCr Percutaneous Rod Ø6.0mm-DEFORMITY
03613720286653	UNiD CoCr Percutaneous Rod Ø6.0mm-DEGEN
03613720286639	UNiD Ti Percutaneous Rod Ø6.0mm-DEFORMITY
03613720286622	UNiD Ti Percutaneous Rod Ø6.0mm-DEGEN
03613720286615	UNiD CoCr Percutaneous Rod Ø5.5mm-DEFORMITY
03613720286608	UNiD CoCr Percutaneous Rod Ø5.5mm-DEGEN
03613720286592	UNiD Ti Percutaneous Rod Ø5.5mm-DEFORMITY
03613720286585	UNiD Ti Percutaneous Rod Ø5.5mm-DEGEN

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