FDA.reportPublic FDA data

Senolo

Primary DI
26952534431035
Brand
Senolo
Company
JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.
Model
5l
Published
2023-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JZRSupport Gels

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZRSupport GelsImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26952534431035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2695253443103526952534431035

GMDN Terms#

Term, Definition table
TermDefinition
Skin topical coupling gelA medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. It is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421315790
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26952534431011Senolo250ml2023-04-06
26952534431028Senolo1l2023-04-06
16952534411122SenoloXD22023-04-06
16952534411139SenoloXD32023-04-06
16952534411146SenoloXD42023-04-06
16952534411153SenoloXD52023-04-06
16952534411160SenoloXD62023-04-06
16952534421022SenoloXB22023-04-06
16952534421039SenoloXB32023-04-06
16952534421046SenoloXB42023-04-06
16952534421053SenoloXB52023-04-06
16952534421060SenoloXB62023-04-06
16952534421114SenoloXB3122023-04-06
16952534421121SenoloXB3362023-04-06
16952534421138SenoloXB4162023-04-06
16952534421145SenoloXB4302023-04-06
16952534421152SenoloXB5302023-04-06
16952534421169SenoloXB5462023-04-06
26952534441027SenoloXP22023-04-06
26952534441034SenoloXP32023-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
26952534431011SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.JZR2023-04-06
26952534431028SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.JZR2023-04-06
00643293028858AzureTRULIFE LIMITEDJZR2023-02-10
00643293028865AzureTRULIFE LIMITEDJZR2023-02-10
00643293028872AzureTRULIFE LIMITEDJZR2023-02-10
00643293028889AzureTRULIFE LIMITEDJZR2023-02-10
00643293028896AzureTRULIFE LIMITEDJZR2023-02-10
00643293028902AzureTRULIFE LIMITEDJZR2023-02-10
00643293028919Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028926Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028933Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028940Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028957Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028964Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028971Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028988Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028995Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293029008Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293029015Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293029022EliteTRULIFE LIMITEDJZR2023-02-10
00643293029039EliteTRULIFE LIMITEDJZR2023-02-10
00643293029046OasisTRULIFE LIMITEDJZR2023-02-10
00643293029053OasisTRULIFE LIMITEDJZR2023-02-10
00643293029060OasisTRULIFE LIMITEDJZR2023-02-10
00643293029077OasisTRULIFE LIMITEDJZR2023-02-10
00643293029084OasisTRULIFE LIMITEDJZR2023-02-10
00643293029091OasisTRULIFE LIMITEDJZR2023-02-10
00643293029107OasisTRULIFE LIMITEDJZR2023-02-10
00643293029114OasisTRULIFE LIMITEDJZR2023-02-10
00643293029121OasisTRULIFE LIMITEDJZR2023-02-10