Kit:balloon, Filler, Access, Drill

FDA UDI

Class II (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name: KIT:BALLOON,FILLER,ACCESS,DRILL FDA UDI
Generic Name: Balloon kyphoplasty kit FDA UDI
Model / Reference: VBBF002 FDA UDI

Identifiers

Primary DI / UDI-DI: 00815212026928 FDA UDI
FDA Product Code: NDN FDA UDI
HRX FDA UDI
KNW FDA UDI
GMDN Term: Balloon kyphoplasty kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 FDA UDI
888.1100 FDA UDI
876.1075 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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 Bone access cannula Orthopaedic cement, non-antimicrobial

Kit:balloon, Filler, Access, Drill by Izi Medical Products Llc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Izi Medical Products Llc

Sources (1)

FDA UDI da178478-f0e5-47d9-8d39-f49b7c7efaa0 32 fields · synced Jun 6, 2026