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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
Patient surgical drape, single-use, non-sterile FDA UDI
Device Name
36" x 28" BandBag - Non-Sterile FDA UDI
Model / Reference
CMS-3628BB-NS FDA UDI
Description
36" x 28" BandBag - Non-Sterile FDA UDI

Identifiers

Primary DI / UDI-DI
00815849020139 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
Patient surgical drape, single-use, non-sterile 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Patient surgical drape, single-use, non-sterile

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 Patient surgical drape, single-use, non-sterile.

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 63a4b2d8-3792-4d2a-a792-c3f12c57df1e 33 fields · synced May 30, 2026