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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
Limb/torso/head restraint, single-use FDA UDI
Device Name
Velcrow Quick Strap - Non-Sterile FDA UDI
Model / Reference
CMS-203 FDA UDI
Description
Velcrow Quick Strap - Non-Sterile FDA UDI

Identifiers

Primary DI / UDI-DI
00815849020122 FDA UDI
FDA Product Code
KID FDA UDI
GMDN Term
Limb/torso/head restraint, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3910 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Limb/torso/head restraint, 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 Limb/torso/head restraint, 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 c705314a-1f1f-45cd-bc29-ac11af0070ac 33 fields · synced May 31, 2026