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Coverlet®

FDA UDI

Class I (US FDA UDI)

by Bsn Medical, Inc.

Identity

Trade Name
Coverlet® FDA UDI
Generic Name
Adhesive bandage FDA UDI
Device Name
COVERLET ELASTIC 70 X 102 TAN 50 EXTRA LARGE PATCH FDA UDI
Model / Reference
78010-00 FDA UDI
Description
COVERLET ELASTIC 70 X 102 TAN 50 EXTRA LARGE PATCH FDA UDI

Identifiers

Catalog Number
78010-00 FDA UDI
Primary DI / UDI-DI
00035664002633 FDA UDI
FDA Product Code
NAD FDA UDI
GMDN Term
Adhesive bandage 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Width — 7 Centimeter FDA UDI
Length — 10 Centimeter FDA UDI

Category: Adhesive bandage

Coverlet® by Bsn Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Adhesive bandage.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bsn Medical, Inc.

Sources (1)

  • FDA UDI 315a874e-7e39-43a3-9c38-432cb4ce6e47 36 fields · synced May 30, 2026