NA

Basic Information

• Brand Name: NA
• Primary DI: 10810050243954
• Version / Model: 9076-00-001
• Company Name: DOMICO MED-DEVICE, LLC
• Labeler DUNS: 081253414
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-12-18
• Public Version: 1
• Public Version Date: 2020-12-28
• Public Version Status: New
• Public Device Record Key: 74e6e164-ff9f-4ea1-bfcc-cf85d7d0be15

Device Description

STRAP, SECURITY, LOOP, 18" x 2"

Device Characteristics

• Single Use: No
• 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: Yes
• Has Manufacturing Date: Yes
• 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
KXJ	Table, Radiologic	Radiology	892.1980	2
FMQ	Restraint, Protective	General Hospital	880.6760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62482	Limb/torso/head restraint, reusable	A non-rigid device, typically a strap(s) or 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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810050243957	GS1
Primary	10810050243954	GS1

Device Sizes

Type	Value	Unit	Text
Length	18	Inch
Width	2	Inch