FDA.reportPublic FDA data

REFINE

Primary DI
06971560452575
Brand
REFINE
Company
Guilin Refine Medical Instrument Co.,LTD.
Model
VAT-3
Published
2023-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JETPick, Massaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JETPick, MassagingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971560452575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971560452575069715604525756971560452575

GMDN Terms#

Term, Definition table
TermDefinition
Dental irrigation/aspiration syringeA hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
407578472
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971560450342REFINEGD42025-06-30
06971560450410REFINEPD4D2025-06-30
06971560450434REFINEGD12025-06-30
06971560450670REFINEGD22025-06-30
06971560450694REFINEGD52025-06-30
06971560450700REFINEGD62025-06-30
06971560450717REFINEPD12025-06-30
06971560450748REFINEPD32025-06-30
06971560450755REFINEPD42025-06-30
06971560450762REFINEED12025-06-30
06971560453466REFINEPT-X22025-06-30
06971560453473REFINEPT-X32025-06-30
06971560453480REFINEPT-X52025-06-30
06971560453497REFINEPT-X62025-06-30
06971560453503REFINEPT-X72025-06-30
06971560452698REFINEMaxCure32023-12-06
06971560453145REFINEMaxCure52023-12-06
06971560453190REFINEMaxCureH2023-12-06
06971560454234REFINEMaxCureG2023-12-06
06971560450045REFINEA-Cure2023-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800019151289PVS TipB& L Biotech, inc.JET2025-04-30
08800019151296PVS TipB& L Biotech, inc.JET2025-04-30
08800019151302PVS TipB& L Biotech, inc.JET2025-04-30
08800019151593DB TipB& L Biotech, inc.JET2025-04-30
08800019151609DB TipB& L Biotech, inc.JET2025-04-30
08800019151616DB TipB& L Biotech, inc.JET2025-04-30
08800019151623DB TipB& L Biotech, inc.JET2025-04-30
08800019151630DS TipB& L Biotech, inc.JET2025-04-30
08800019151647DS TipB& L Biotech, inc.JET2025-04-30
08800019151654DS TipB& L Biotech, inc.JET2025-04-30
08800019151661DS TipB& L Biotech, inc.JET2025-04-30
08800019151678TS TipB& L Biotech, inc.JET2025-04-30
08800019151685TS TipB& L Biotech, inc.JET2025-04-30
08800019151692TS TipB& L Biotech, inc.JET2025-04-30
08800019151708TS TipB& L Biotech, inc.JET2025-04-30
08800019151715TS TipB& L Biotech, inc.JET2025-04-30
08800019151722TS TipB& L Biotech, inc.JET2025-04-30
00883205031730OpalpixULTRADENT PRODUCTS, INC.JET2025-03-12
00070942008143GUM® SUNSTAR AMERICAS, INC.JET2025-01-08
08800019151517CI Tip B& L Biotech, inc.JET2024-12-16
08800019151524CI TipB& L Biotech, inc.JET2024-12-16
08800019151319DS TipB& L Biotech, inc.JET2024-12-05
08800019151326DS TipB& L Biotech, inc.JET2024-12-05
08800019151333DS TipB& L Biotech, inc.JET2024-12-05
08800019151340DS TipB& L Biotech, inc.JET2024-12-05
08800019151357DS TipB& L Biotech, inc.JET2024-12-05
08800019151364DS TipB& L Biotech, inc.JET2024-12-05
08800019151371DS TipB& L Biotech, inc.JET2024-12-05
08800019151388DS TipB& L Biotech, inc.JET2024-12-05
00070942007849GUM® SUNSTAR AMERICAS, INC.JET2024-10-30