Pair Rotating Luer Lock Connectors

FDA UDI

Class I (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name: Pair Rotating Luer Lock Connectors FDA UDI
Generic Name: Orthopaedic cement dispenser FDA UDI
Model / Reference: ASC0010 FDA UDI

Identifiers

Primary DI / UDI-DI: 00815212026393 FDA UDI
FDA Product Code: OAR FDA UDI
GMDN Term: Orthopaedic cement dispenser FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4200 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

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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic cement dispenser

Pair Rotating Luer Lock Connectors by Izi Medical Products Llc — 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: Izi Medical Products Llc

Sources (1)

FDA UDI 7bf9995a-e7be-4176-b7ff-3dbb45aeb373 32 fields · synced May 30, 2026