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Awi

FDA UDI

Class II (US FDA UDI)

by Apex (Guangzhou) Tools & Orthopedics Co.

Identity

Trade Name
AWI FDA UDI
Generic Name
Disposable surgical irrigation/aspiration system FDA UDI
Device Name
PULSE IRRIGATOR FDA UDI
Model / Reference
209-00 FDA UDI
Description
PULSE IRRIGATOR FDA UDI

Identifiers

Primary DI / UDI-DI
06957277200326 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

Yes

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

Awi by Apex (Guangzhou) Tools & Orthopedics Co. — 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

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Manufacturer

Manufacturer
Apex (Guangzhou) Tools & Orthopedics Co.

Sources (1)

  • FDA UDI ff60a464-a068-43e4-b628-1310e73f6c21 33 fields · synced Jun 12, 2026