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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
Birthing/delivery kit FDA UDI
Device Name
Curaplex OB Kit Hospital FDA UDI
Model / Reference
44260 FDA UDI
Description
Curaplex OB Kit Hospital FDA UDI

Identifiers

Primary DI / UDI-DI
00815277021050 FDA UDI
FDA Product Code
FMI FDA UDI
GJE FDA UDI
FMF FDA UDI
GMDN Term
Birthing/delivery kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5570 FDA UDI
862.1675 FDA UDI
880.5860 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: Birthing/delivery kit

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

Similar devices

Also classified as Birthing/delivery kit.

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 5e8af2d1-2e0b-4d93-a3ef-a0ca859e7fe4 33 fields · synced May 31, 2026