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ComfiTel

FDA UDI

Class I (US FDA UDI)

by Dermarite Industries Llc

Identity

Trade Name
ComfiTel FDA UDI
Generic Name
Synthetic polymer semi-permeable film dressing, wound-nonadherent FDA UDI
Model / Reference
56470 FDA UDI

Identifiers

Primary DI / UDI-DI
00714196390547 FDA UDI
FDA Product Code
NAD FDA UDI
GMDN Term
Synthetic polymer semi-permeable film dressing, wound-nonadherent 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

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

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Synthetic polymer semi-permeable film dressing, wound-nonadherent

ComfiTel by Dermarite Industries Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synthetic polymer semi-permeable film dressing, wound-nonadherent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dermarite Industries Llc

Sources (1)

  • FDA UDI 6467ab9a-d869-42d4-bfd8-c82128ec879b 32 fields · synced Jun 8, 2026