Xtra

FDA UDI

Class II (US FDA UDI)

by Sorin Group Italia Srl

Identity

Trade Name: XTRA FDA UDI
Generic Name: Red blood cell-recovery autotransfusion system FDA UDI
Model / Reference: PROCEDURE SET TX/55 FDA UDI

Identifiers

Primary DI / UDI-DI: 08033178110051 FDA UDI
510(k) Number: K101586 FDA UDI
FDA Product Code: CAC FDA UDI
GMDN Term: Red blood cell-recovery autotransfusion system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5830 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Red blood cell-recovery autotransfusion system

Xtra by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Red blood cell-recovery autotransfusion system.

Global Blood Resources — GLOBAL BLOOD RESOURCES, LLC · Class II
C.A.T.S — Fresenius Kabi · Class II
XTRA — SORIN GROUP ITALIA SRL · Class II
BRAT 2 — SORIN GROUP ITALIA SRL · Class II
XTRA — SORIN GROUP ITALIA SRL · Class II
BRAT 2 — SORIN GROUP ITALIA SRL · Class II
XTRA — SORIN GROUP ITALIA SRL · Class II
BRAT 2 — SORIN GROUP ITALIA SRL · Class II

Cleared under the same submission

K101586 also covers:

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: Sorin Group Italia Srl

Sources (1)

FDA UDI 03ec8be5-230d-42be-8297-d27d6cc00b83 33 fields · synced Jun 8, 2026