Curaplex

FDA UDI

Class I (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Woven gauze pad, non-antimicrobial FDA UDI
Device Name: CURAPLEX STERILE, GAUZE SPONGE, WOVEN, 4IN X 4IN, 8-PLY, 2EA/PK, 50PK/BX, 12BX/CS FDA UDI
Model / Reference: 1212-12113 FDA UDI
Description: CURAPLEX STERILE, GAUZE SPONGE, WOVEN, 4IN X 4IN, 8-PLY, 2EA/PK, 50PK/BX, 12BX/CS FDA UDI

Identifiers

Catalog Number: 1212-12113 FDA UDI
Primary DI / UDI-DI: 00810094575663 FDA UDI
FDA Product Code: NAB FDA UDI
GMDN Term: Woven gauze pad, non-antimicrobial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4014 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Woven gauze pad, non-antimicrobial

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bound Tree Medical, Llc

Sources (1)

FDA UDI 07b0a5be-0cf2-46bb-a655-eb358bd7463a 34 fields · synced Jun 6, 2026