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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
Utility forceps, single-use FDA UDI
Device Name
9.5" Serrated Sponge Forcep - Sterile FDA UDI
Model / Reference
CMS-631-SC FDA UDI
Description
9.5" Serrated Sponge Forcep - Sterile FDA UDI

Identifiers

Primary DI / UDI-DI
00815849021952 FDA UDI
FDA Product Code
GEN FDA UDI
GMDN Term
Utility forceps, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Utility forceps, single-use

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 Utility forceps, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Custom Assemblies, Inc.

Sources (1)

  • FDA UDI f682e10f-7ab3-49aa-8562-ea760331e503 33 fields · synced May 30, 2026