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Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name
Curaplex FDA UDI
Generic Name
Visitor hygiene coverall FDA UDI
Device Name
PERSONAL PROTECTION KIT WITH 5XL TYCHEM COVERALL 12/CS FDA UDI
Model / Reference
2909005XL FDA UDI
Description
PERSONAL PROTECTION KIT WITH 5XL TYCHEM COVERALL 12/CS FDA UDI

Identifiers

Catalog Number
2909005XL FDA UDI
Primary DI / UDI-DI
00815277027489 FDA UDI
FDA Product Code
OKH FDA UDI
GMDN Term
Visitor hygiene coverall FDA UDI

Classification

Device Class
Class II 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

Yes

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: Surgical/medical respirator, non-antimicrobial, single-useShoe coverEye splash shield, single-useVisitor hygiene coverall

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

Similar devices

Also classified as Nitrile examination/treatment glove, non-powdered, antimicrobial.

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 3f216483-4046-4f75-a67c-655db94e6e79 34 fields · synced May 30, 2026