FDA.report

Affinity Home with accessories

Primary DI
07290017249063
Brand
Affinity Home with accessories
Company
TAVGER LTD
Model
FG00016
Device description
Affinity G.J.S with accessories MP
Published
2022-03-24
Public version status
New
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
07290017249063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290017249063072900172490637290017249063

GMDN Terms

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

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
07290017249070Handpiece Affinity G.J.SFG000222022-03-24
07290017249018Disposable tips boxFG000062017-07-07
07290017249002Disposable tips boxAFHP250012017-07-07
07290017249001Affinity with accessoriesAF10160HP2502017-07-07

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