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TopCare health

FDA UDI

Class I (US FDA UDI)

by Topco Associates, LLC

Identity

Trade Name
TopCare health FDA UDI
Generic Name
Exudate-absorbent dressing, hydrophilic-gel, non-sterile FDA UDI
Device Name
Hydrocolloid Blister Cushions, toes and heels, 1.65 IN x 2.67 IN (42 mm x 68 mm); 1.33 IN x 2.12 IN (34 mm x 54 mm); 0.66 IN x 2.32 IN (17 mm x 59 mm) FDA UDI
Model / Reference
036800259775 FDA UDI
Description
Hydrocolloid Blister Cushions, toes and heels, 1.65 IN x 2.67 IN (42 mm x 68 mm); 1.33 IN x 2.12 IN (34 mm x 54 mm); 0.66 IN x 2.32 IN (17 mm x 59 mm) FDA UDI

Identifiers

Primary DI / UDI-DI
00036800259775 FDA UDI
FDA Product Code
NAD FDA UDI
GMDN Term
Exudate-absorbent dressing, hydrophilic-gel, non-sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Exudate-absorbent dressing, hydrophilic-gel, non-sterile

TopCare health by Topco Associates, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exudate-absorbent dressing, hydrophilic-gel, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Topco Associates, LLC

Sources (1)

  • FDA UDI 20464f26-2eeb-4c78-aff8-0b1cc682d1dd 34 fields · synced Jun 1, 2026