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SureSeal

FDA UDI

Class I (US FDA UDI)

by Facet Technologies, LLC.

Identity

Trade Name
SureSeal FDA UDI
Generic Name
Pressure bandage, non-latex, sterile FDA UDI
Device Name
SureSeal Pressure Bandage, 30mm x 72mm FDA UDI
Model / Reference
Extra Large FDA UDI
Description
SureSeal Pressure Bandage, 30mm x 72mm FDA UDI

Identifiers

Catalog Number
85200 FDA UDI
Primary DI / UDI-DI
00894743001024 FDA UDI
FDA Product Code
KGX FDA UDI
GMDN Term
Pressure bandage, non-latex, sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5240 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

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pressure bandage, non-latex, sterile

SureSeal by Facet Technologies, LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pressure bandage, non-latex, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Facet Technologies, LLC.

Sources (1)

  • FDA UDI d094f147-b442-4d21-b13b-b2e3d97f736a 34 fields · synced May 30, 2026