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Custom Medical Specialties, Inc.

FDA UDI

Class II (US FDA UDI)

by Custom Assemblies, Inc.

Identity

Trade Name
Custom Medical Specialties, Inc. FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Procedure Kit FDA UDI
Model / Reference
CMS-9114 FDA UDI
Description
Procedure Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00815849023703 FDA UDI
FDA Product Code
LRO FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

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

Similar devices

Also classified as General surgical procedure kit, non-medicated, 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 225d2840-18a6-4f5a-b3cb-d6b7aa580388 33 fields · synced Jun 1, 2026