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Pfab Small

FDA UDI

Class I (US FDA UDI)

by Sun-Scientific Inc.

Identity

Trade Name
PFAB SMALL FDA UDI
Generic Name
Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI
Device Name
Silicone Foam Dressing with Air Bolster FDA UDI
Model / Reference
PFAB-S FDA UDI
Description
Silicone Foam Dressing with Air Bolster FDA UDI

Identifiers

Catalog Number
PFAB-S FDA UDI
Primary DI / UDI-DI
00856525007365 FDA UDI
510(k) Number
K070457 FDA UDI
FDA Product Code
MHW FDA UDI
MGP FDA UDI
NAC FDA UDI
GMDN Term
Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5075 FDA UDI
878.4018 FDA UDI
Commercial Distribution
Not 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

No

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

Yes

FDA UDI

Pfab Small by Sun-Scientific Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K070457 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sun-Scientific Inc.

Sources (1)

  • FDA UDI 4b398bc5-b820-4564-bebb-267fc78161e4 37 fields · synced Jun 1, 2026