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Surgiphor

FDA UDI

Class II (US FDA UDI)

by Carefusion 2200, Inc.

Identity

Trade Name
Surgiphor FDA UDI
Generic Name
Pressure-regulated wound irrigation solution applicator, manual FDA UDI
Device Name
Surgiphor Antimicrobial Irrigation System FDA UDI
Model / Reference
910110 FDA UDI
Description
Surgiphor Antimicrobial Irrigation System FDA UDI

Identifiers

Catalog Number
910110 FDA UDI
Primary DI / UDI-DI
00382909101102 FDA UDI
510(k) Number
K221504 FDA UDI
FDA Product Code
FQH FDA UDI
FRO FDA UDI
GMDN Term
Pressure-regulated wound irrigation solution applicator, manual 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pressure-regulated wound irrigation solution applicator, manual

Surgiphor by Carefusion 2200, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pressure-regulated wound irrigation solution applicator, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carefusion 2200, Inc.

Sources (1)

  • FDA UDI a87a04a7-faa7-4c91-b4a5-91499cdf28f9 37 fields · synced Sep 18, 2026