FDA.reportPublic FDA data

Disposable tips box

Primary DI
07290017249018
Brand
Disposable tips box
Company
TAVGER LTD
Model
FG00006
Device description
Affinity is a device used to clean a tissue (skin) by a tiny jets of sterile fluid. The device consists of tip with the nozzles arragement,tubing to connect to a container of sterile fluid, and a means ofpropelling the fluid through the nozzles, such as an electric roller pump.
Published
2017-07-07
Public version status
Update
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
17290017249022PackageGS110In Commercial Distribution
07290017249018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001724902217290017249022
07290017249018072900172490187290017249018

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation system nozzleA surgically-invasive device designed to be attached to the distal end of a lavage system or kit handpiece to intraoperatively function as an applicator/nozzle that produces an intentional jet, stream or spray of sterile fluid (typically saline) from its aperture to the site of operation during a surgical intervention (e.g., trauma, soft tissue application and orthopaedic) for the purpose of removing tissue, bone debridement and/or bone cement residue, and to clean the site; it may in addition perform aspiration (suction). It is available in many designs (e.g., fan spray, built-in filter, splash shield, brush); however, it is not a single-hole cannula/tubing. This is a single-use device.

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
07290017249056Affinity G.J.S with accessories FG000142022-03-24
07290017249063Affinity Home with accessories FG000162022-03-24
07290017249070Handpiece Affinity G.J.SFG000222022-03-24
07290017249001Affinity with accessoriesFG000042017-07-07
07290017249002Disposable tips boxAFHP250012017-07-07

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