FDA.report

ENDORET SYSTEM V CENTRIFUGE

Primary DI
08435389816997
Brand
ENDORET SYSTEM V CENTRIFUGE
Company
BIOTECHNOLOGY INSTITUTE SL
Model
PRGF S.V
Published
2021-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08435389816997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08435389816997084353898169978435389816997

GMDN Terms

TermDefinition
Haematological concentrate system centrifugeA mains electricity (AC-powered) device typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm) from a small volume of autologous (patient's own) blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). The concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. It includes a rotor head with a receptacle(s) for dedicated autologous specimen processing equipment. This device may be a tabletop or floor unit; may include refrigeration.

Sterilization Methods

Method

Regulatory Flags

DUNS number
461665312
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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