ShotBlocker®

Basic Information

• Brand Name: ShotBlocker®
• Primary DI: 00859911004054
• Version / Model: 801-SD
• Catalog Number: 801-SD
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2021-12-16
• Public Version: 3
• Public Version Date: 2023-07-17
• Public Version Status: Update
• Public Device Record Key: 105b4c3d-8ca2-4cf6-a5e7-32a942f19d88

Device Description

Over the counter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
LYG	MASSAGER, THERAPEUTIC, MANUAL	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62733	Injection site desensitizer, tactile, reusable	A non-sterile, noninvasive device intended to be used to manually apply tactile pressure stimuli to a skin-surface injection site, prior to/during injection, to reduce the pain/anxiety associated with injection. It is typically a synthetic polymer device with a textured surface and may be hand-held or intended to be attached to the syringe/autoinjector. It is intended for use in the home or healthcare facility. 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	10859911004051	GS1
Primary	00859911004054	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]