ShotBlocker SB-08004

GUDID 10714646000771

ShotBlocker 1,000 ct

Bionix, LLC

Injection site desensitizer, tactile, reusable

• Primary Device ID: 10714646000771
• NIH Device Record Key: 8028b7de-cd1c-4479-9221-f17167be6fc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShotBlocker
• Version Model Number: SB-08004
• Catalog Number: SB-08004
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 1000
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714646000774 [Primary]
GS1	10714646000771 [Unit of Use]

FDA Product Code

• LYG: MASSAGER, THERAPEUTIC, MANUAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-25
• Device Publish Date: 2024-03-15

Devices Manufactured by Bionix, LLC

• 00714646000736 - OtoClear SprayWash System, Single Use Sample: 2025-09-09 OtoClear SprayWash System, Single Use Sample
• 10859911004792 - Tabletop Waterpik Adapter Wands: 2025-09-09 Tabletop Waterpik Adapter Wands
• 00714646001474 - Pelvis Belly Replacement Leg Cushion: 2025-08-29 Pelvis Belly Replacement Leg Cushion
• 00714646001481 - Pelvis Belly Replacement Arm Rest Cushion: 2025-08-29 Pelvis Belly Replacement Arm Rest Cushion
• 00714646001498 - Pelvis Belly Replacement Stomach Cushion - Medium: 2025-08-29 Pelvis Belly Replacement Stomach Cushion - Medium
• 00714646001504 - Pelvis Belly Replacement Face Cushion Assembly: 2025-08-29 Pelvis Belly Replacement Face Cushion Assembly
• 00714646001511 - Pelvis Belly Replacement Stomach Cushion - Small: 2025-08-29 Pelvis Belly Replacement Stomach Cushion - Small
• 10714646001099 - Microsuction Stater Pack: 2025-07-16 Microsuction Starter Pack