Custom Medical Specialties, Inc.

Basic Information

• Brand Name: Custom Medical Specialties, Inc.
• Primary DI: 00815849020122
• Version / Model: CMS-203
• Company Name: CUSTOM ASSEMBLIES, INC.
• Labeler DUNS: 948904735
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-22
• Public Version: 4
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: c705314a-1f1f-45cd-bc29-ac11af0070ac

Device Description

Velcrow Quick Strap - Non-Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	890.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44851	Limb/torso/head restraint, single-use	A non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815849020122	GS1