UNiD OCT B33223500-02

GUDID 03613720269403

UNiD CoCr Rod Ø3.5mm 4+ LV

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	03613720269403
NIH Device Record Key	a6646b32-5954-43b0-9f57-0534a409774b
Commercial Distribution Status	In Commercial Distribution
Brand Name	UNiD OCT
Version Model Number	B33223500-02
Catalog Number	B33223500-02
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	true
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	03613720269403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153169

FDA Product Code

NKG	Orthosis, Cervical Pedicle Screw Spinal Fixation

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

[03613720269403]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2021-08-20
Device Publish Date	2017-09-12

On-Brand Devices [UNiD OCT]

03613720269403	UNiD CoCr Rod Ø3.5mm 4+ LV
03613720269397	UNiD CoCr Rod Ø3.5mm 1-3 LV
03613720269311	UNiD Ti Rod Ø3.5mm 4+ LV
03613720269304	UNiD Ti Rod Ø3.5mm 1-3 LV
03613720286905	UNiD Ti Dual Diameter Rod Ø3.5mm/Ø5.5mm
03613720286899	UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm
03613720286882	UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø5.5mm
03613720286875	UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.