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Curaplex

FDA UDI

Class I (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name
Curaplex FDA UDI
Generic Name
Antiseptic skin towelette FDA UDI
Device Name
Curaplex Personal Protection Kit Compact, incl Impervious Gown FDA UDI
Model / Reference
29220S FDA UDI
Description
Curaplex Personal Protection Kit Compact, incl Impervious Gown FDA UDI

Identifiers

Primary DI / UDI-DI
00815277020756 FDA UDI
FDA Product Code
LYU FDA UDI
GMDN Term
Antiseptic skin towelette FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Isolation gown, single-useSurgical/medical respirator, non-antimicrobial, single-useNitrile examination/treatment glove, non-powdered, antimicrobialLaboratory waste receptacle IVD

Curaplex by Bound Tree Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Antiseptic skin towelette.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bound Tree Medical, Llc

Sources (1)

  • FDA UDI dbb58afb-5cee-4327-a216-6a26df613524 33 fields · synced May 31, 2026