Arthrex®

FDA UDI

Class I (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: General-purpose centrifuge IVD FDA UDI
Device Name: CENTRIFUGE, ROTOFIX 32, 110V FDA UDI
Model / Reference: ABS-10020 FDA UDI
Description: CENTRIFUGE, ROTOFIX 32, 110V FDA UDI

Identifiers

Catalog Number: ABS-10020 FDA UDI
Primary DI / UDI-DI: 00888867001879 FDA UDI
FDA Product Code: JQC FDA UDI
GMDN Term: General-purpose centrifuge IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: General-purpose centrifuge IVD

Arthrex® by Arthrex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Medical Centrifuge LX-210L750R — Qingdao Haier Biomedical Technology Co., Ltd. · Class A
cence — HUNAN XIANG YI LABORATORY INSTRUMENT DEVELOPMENT CO.,LTD. · Class A
406 — GYROZEN · Class A

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: Arthrex, Inc.

Sources (1)

FDA UDI a286ba01-8c49-4fc3-87d5-fa609a77aeb0 35 fields · synced May 31, 2026