Mediox

FDA UDI

Class I (US FDA UDI)

by Mediox Medical Service Ltd

Identity

Trade Name: Mediox FDA UDI
Generic Name: Balloon kyphoplasty kit FDA UDI
Device Name: Mediox medical, Kyphoplasty Tool Kit,include guide wire,drill,bone cement filler ,puncture needle and cannula,dilator and working cannula. Model FA08409 Product content is Puncture needle 3.7 FDA UDI
Model / Reference: FA08409 FDA UDI
Description: Mediox medical, Kyphoplasty Tool Kit,include guide wire,drill,bone cement filler ,puncture needle and cannula,dilator and working cannula. Model FA08409 Product content is Puncture needle 3.7 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850054612199 FDA UDI
FDA Product Code: OCJ FDA UDI
GMDN Term: Balloon kyphoplasty kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Balloon kyphoplasty kit

Mediox by Mediox Medical Service Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Mediox Medical Service Ltd

Sources (1)

FDA UDI 422fcdb2-e27c-443f-be12-a68288eafab9 33 fields · synced May 30, 2026