FDA.reportPublic FDA data

Affinity G.J.S with accessories

Primary DI
07290017249056
Brand
Affinity G.J.S with accessories
Company
TAVGER LTD
Model
FG00014
Device description
Affinity G.J.S with accessories ASS
Published
2022-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017249056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017249056072900172490567290017249056

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/orthopaedic lavage control unitA mains electricity (AC-powered) device designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) by regulating a pulsatile jet of sterile fluid (typically saline). It is typically an electromechanical unit that includes a pump for irrigation/infusion of fluids, an extractor (frequently using vacuum), and controls for the rate of irrigation/infusion and withdrawal of the fluid; it usually operates with separate kits that include handpieces, tubing, and detachable tips (applicators) of various shapes and sizes for specific surgical applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533284357
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017249032MesoStripFG000102022-03-24
07290017249049BioRef-DCFG000192022-03-24
07290017249063Affinity Home with accessories FG000162022-03-24
07290017249070Handpiece Affinity G.J.SFG000222022-03-24
07290017249001Affinity with accessoriesFG000042017-07-07
07290017249018Disposable tips boxFG000062017-07-07
07290017249002Disposable tips boxAFHP250012017-07-07

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