Vertebroplasty Needle Kit, 8G, Diamond Tip

FDA UDI

Class I (US FDA UDI)

by Möller Medical GmbH

Identity

Trade Name: Vertebroplasty Needle Kit, 8G, Diamond Tip FDA UDI
Generic Name: Orthopaedic cement preparation/delivery kit FDA UDI
Device Name: The “Vertebroplasty Needle Kit“, part of the Synthes’ Vertecem / Vertecem V+ System, is a sterile packed kit for Vertebroplasty procedures. The needle kit is to be used in conjunction with PMMA cement and appropriate syringes. FDA UDI
Model / Reference: 10001541US FDA UDI
Description: The “Vertebroplasty Needle Kit“, part of the Synthes’ Vertecem / Vertecem V+ System, is a sterile packed kit for Vertebroplasty procedures. The needle kit is to be used in conjunction with PMMA cement and appropriate syringes. FDA UDI

Identifiers

Catalog Number: 03.702.216S FDA UDI
Primary DI / UDI-DI: 04260277175573 FDA UDI
FDA Product Code: KIH FDA UDI
FZX FDA UDI
GMDN Term: Orthopaedic cement preparation/delivery kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4200 FDA UDI
878.4800 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

Yes

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: Orthopaedic cement preparation/delivery kit

Vertebroplasty Needle Kit, 8G, Diamond Tip by Möller Medical GmbH — 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: Möller Medical GmbH

Sources (1)

FDA UDI 0e5e1ec7-31c2-4486-86d1-55d55b0b7d59 34 fields · synced Jun 9, 2026