W114

Basic Information

• Brand Name: W114
• Primary DI: 00197513008477
• Version / Model: SEW114-XSM
• Company Name: BURLINGTON MEDICAL, LLC
• Labeler DUNS: 083381202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-08
• Public Version: 1
• Public Version Date: 2023-02-16
• Public Version Status: New
• Public Device Record Key: 70cea940-c13b-4f38-8537-d8380c42fec3

Device Description

Custom: W114 One Piece Wrap Quick Release Side and Shoulder Closure .35mm Xenolite 700-E Size Extra Small Male

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
IWO	Apron, Protective	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38355	Radiation shielding apron	A full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00197513008477	GS1