Custom Healthcare Systems Inc.

FDA UDI

Class I (US FDA UDI)

by Manus Medical, LLC

Identity

Trade Name: Custom Healthcare Systems Inc. FDA UDI
Generic Name: Cotton wool roll, sterile FDA UDI
Model / Reference: D4-225 FDA UDI

Identifiers

Primary DI / UDI-DI: 00811870030260 FDA UDI
FDA Product Code: KXG FDA UDI
GMDN Term: Cotton wool roll, sterile FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6025 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Cotton wool roll, sterile

Custom Healthcare Systems Inc. by Manus 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: Manus Medical, LLC

Sources (1)

FDA UDI f6fcf812-50a4-45e1-9145-9e9d7531a191 32 fields · synced Jun 1, 2026