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Surgaflex PainGuard

FDA UDI

Class U (US FDA UDI)

by Imbed Biosciences, Inc.

Identity

Trade Name
Surgaflex PainGuard FDA UDI
Generic Name
Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial FDA UDI
Device Name
Surgaflex PainGuard, 4cm x 20cm FDA UDI
Model / Reference
SFPG0420 FDA UDI
Description
Surgaflex PainGuard, 4cm x 20cm FDA UDI

Identifiers

Primary DI / UDI-DI
00850019162356 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial FDA UDI

Classification

Device Class
U 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

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

Surgaflex PainGuard by Imbed Biosciences, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Imbed Biosciences, Inc.

Sources (1)

  • FDA UDI 571f93ba-6d5c-43ea-8a3a-2a2123480cfd 35 fields · synced May 30, 2026