Custom Medical Specialties, Inc.

FDA UDI

Class I (US FDA UDI)

by Custom Assemblies, Inc.

Identity

Trade Name: Custom Medical Specialties, Inc. FDA UDI
Generic Name: Absorbent underpad, sterile FDA UDI
Device Name: Absorbent Pad - Sterile FDA UDI
Model / Reference: CMS-6025 FDA UDI
Description: Absorbent Pad - Sterile FDA UDI

Identifiers

Primary DI / UDI-DI: 00815849021815 FDA UDI
FDA Product Code: FRL FDA UDI
GMDN Term: Absorbent underpad, sterile FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5300 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

FDA UDI

Category: Absorbent underpad, sterile

Custom Medical Specialties, Inc. by Custom Assemblies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Absorbent underpad, sterile.

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HK Sterile Super Absorbent OR Table Sheet 31" x 71" — HK SURGICAL INC. · Class I
Custom Medical Specialties, Inc. — CUSTOM ASSEMBLIES, INC. · Class I

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: Custom Assemblies, Inc.

Sources (1)

FDA UDI 3b58d1ae-9482-4024-b52f-f0b99e4b8339 33 fields · synced Jun 8, 2026