FDA.reportPublic FDA data

ShotBlocker®

Primary DI
00714646000842
Brand
ShotBlocker®
Company
Bionix, LLC
Model
SB-8003
Catalog number
8003
Device description
ShotBlocker® 2000 ct. Retail
Published
2022-10-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYGMASSAGER, THERAPEUTIC, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYGMassager, Therapeutic, ManualPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714646000842PrimaryGS10
10714646000849Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646000842007146460008427146460008420714646000842
1071464600084910714646000849

GMDN Terms#

Term, Definition table
TermDefinition
Injection site desensitizer, tactile, reusableA 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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)551-7096Bionix@bionix.com

Regulatory Flags#

DUNS number
117844489
Device count
2000
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
007146460007432724527245272452024-07-11
007146460007502727527275272752024-07-11
0071464600098927247SP-27247272472022-10-27
00714646001535Lighted Magnetic Foreign Body Removal Tool352535252026-03-03
10714646001532Lighted Magnetic Foreign Body Removal Tool352535252026-03-03
00714646001627Lighted Magnetic Foreign Body Removal Tool352135212026-03-03
00714646001528Lighted Articulating Ear Curettes - Refill251225122025-11-22
00714646001559Rechargeable Light Source360036002025-11-22
00714646001566ClearLook Variety Pack with Rechargeable Light Source364536452025-11-22
00714646001573ClearLook LEC, Sample Pack-Curettes Only23300233002025-11-22
00714646001580ClearLook Variety Pack334533452025-11-22
00714646001597ClearLook CeraSpoon335033502025-11-22
00714646001603ClearLook Variety, 50ct Refill Pack344534452025-11-22
00714646001610ClearLook CeraSpoon, 50ct Refill Pack345034502025-11-22
00859911004160OtoClear Tips720072002017-01-28
00714646001092Lighted Microsuction System2650LS-026502025-07-08
00714646001108Microsuction Replacement Pack2651LS-026512025-07-08
00859911004795Tabletop Waterpik Adapter Wands27210272102024-07-11
00714646000736OtoClear SprayWash System, Single Use Sample27291272912024-07-11
10859911004792Tabletop Waterpik Adapter Wands27210272102024-07-11

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Primary DI, Brand, Company table
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00754028803203Fascia Buddy Silicone Cups - Lite - MediumEastern Currents Distributing LtdLYG2025-08-15
00754028803302Fascia Buddy Silicone Cups - Lite - Small Eastern Currents Distributing LtdLYG2025-08-15
00754028803401Fascia Buddy Silicone Cups - Lite - Extra Small Eastern Currents Distributing LtdLYG2025-08-15
00754028821511Fascia Buddy Silicone Cups Set of 4 Eastern Currents Distributing LtdLYG2025-08-15
00754028821610Fascia Buddy Silicone Cups - Large Eastern Currents Distributing LtdLYG2025-08-15
00754028821719Fascia Buddy Silicone Cups - MediumEastern Currents Distributing LtdLYG2025-08-15
00754028821818Fascia Buddy Silicone Cups - SmallEastern Currents Distributing LtdLYG2025-08-15
00754028821917Fascia Buddy Silicone Cups- Extra SmallEastern Currents Distributing LtdLYG2025-08-15
00754028870007Fascia Buddy Square Cupping Set – 20 piecesEastern Currents Distributing LtdLYG2025-08-15
00754028871011Fascia Buddy Square Cup - Extra Large Eastern Currents Distributing LtdLYG2025-08-15
00754028872025Fascia Buddy Square Cup - Large Eastern Currents Distributing LtdLYG2025-08-15
00754028873039Fascia Buddy Square Cup - MediumEastern Currents Distributing LtdLYG2025-08-15
00754028874043Fascia Buddy Square Cup - Small Eastern Currents Distributing LtdLYG2025-08-15
00754028875057Fascia Buddy Square Cup - Extra SmallEastern Currents Distributing LtdLYG2025-08-15
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08052464700158Tesmed CELLULITEFELDI SRLLYG2025-05-14
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00073950338011WaterPik Transform RV with PowerPulseWATER PIK, INC.LYG2025-01-29
00073950339230WaterPik Caddy Buddy with PowerPulseWATER PIK, INC.LYG2025-01-29
00073950339322WaterPik Caddy Buddy with PowerPulseWATER PIK, INC.LYG2025-01-29
00073950339346WaterPik Caddy Buddy with PowerPulseWATER PIK, INC.LYG2025-01-29
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