FDA.reportPublic FDA data

Juicebox

Primary DI
00851354004073
Brand
Juicebox
Company
AVINGER, INC.
Model
J100
Catalog number
J100
Device description
Juicebox is an optional accessory to facilitate catheter tip rotation when using a compatible Avinger catheter. It consists of a handle with a Rotation Toggle Switch and a Release Button. Juicebox is designed to be placed over the catheter handle. This accessory is irradiated for sterility and is intended for single use only. When Juicebox is properly placed over a catheter handle, it locks into place. Depressing the Rotation Toggle Switch activates the power for rotation in either the clockwise or counterclockwise directions. The Release Button releases Juicebox so that it can be removed from the catheter handle.The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger catheter.
Published
2019-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111704000AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOXAvinger, Inc.2011-09-09DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851354004073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851354004073008513540040738513540040730851354004073

GMDN Terms#

Term, Definition table
TermDefinition
Torque manipulation deviceA sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
650-241-7030tlawson@avinger.com

Regulatory Flags#

DUNS number
003152968
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851354004417Pantheris SVA140-SVA140-SV2019-08-02
00851354004189Ocelot IIIO200O2002019-03-21
00851354004233Ocelot IVO250O2502019-03-21
00851354004271CO2C100C1002019-03-21
00851354004370PantherisA400A4002019-03-21
00851354004387Pantheris A400XA400X2019-03-21
00851354004554Tigereye STO350O3502023-07-24
00851354004493TigereyeO300O3002023-03-14
00851354004509Lightbox L3L300L3002024-01-29
00851354004578Pantheris LVLVA110-LV2024-01-29
00851354004264Sterile DrapeSD100SD1002019-03-21
00851354004004WildcatW400W4002019-03-21
00851354004028WildcatE400E4002019-03-21
00851354004042Kittykat IIW550`W5502019-03-21
00851354004059Kittykat IIE550E5502019-03-21
00851354004127Lightbox Umbilical U100U1002019-03-21
00851354004141Ocelot PIXLP135P1352019-03-21
00851354004301Lightbox Umbilical U250U2502019-03-21

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