FDA.report

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 of propelling 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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FQHLavage, Jet

Product Code Classifications

CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
17290017249022PackageGS110In Commercial Distribution
07290017249018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1729001724902217290017249022
07290017249018072900172490187290017249018

GMDN Terms

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

Regulatory Flags

DUNS number
533284357
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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
07290017249002Disposable tips boxAFHP250012017-07-07
07290017249001Affinity with accessoriesAF10160HP2502017-07-07

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