← Back to catalogue

iTool® APEXPULSE™

FDA UDI

Class II (US FDA UDI)

by Apex (Suzhou) Medical Products Company

Identity

Trade Name
iTool® APEXPULSE™ FDA UDI
Generic Name
Disposable surgical irrigation/aspiration system FDA UDI
Device Name
Disposable Pulse Lavage Component Kit FDA UDI
Model / Reference
201-02-00 FDA UDI
Description
Disposable Pulse Lavage Component Kit FDA UDI

Identifiers

Catalog Number
201-02-00 FDA UDI
Primary DI / UDI-DI
06972130470012 FDA UDI
FDA Product Code
FQH FDA UDI
GMDN Term
Disposable surgical irrigation/aspiration system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Disposable surgical irrigation/aspiration system

iTool® APEXPULSE™ by Apex (Suzhou) Medical Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Disposable surgical irrigation/aspiration system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Apex (Suzhou) Medical Products Company

Sources (1)

  • FDA UDI 29023e2c-7a47-4cce-a337-753c6a6945dd 34 fields · synced May 31, 2026