FDA.reportPublic FDA data

Next PRP

Primary DI
08681092003111
Brand
Next PRP
Company
T-BIYOTEKNOLOJI LABORATUVAR ESTETIK MEDIKAL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI
Model
N500
Catalog number
N500
Device description
Next PRP Syringe
Published
2019-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08681092003111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08681092003111086810920031118681092003111

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of sterile devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It typically includes a blood withdrawal set, tubes, and syringes. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. The glue-like product is applied to the surface of the injured tissue or bone where its adherent properties form a haemostatic barrier and enhance regeneration. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+902242468522info@tlab.com.tr

Regulatory Flags#

DUNS number
505280884
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08682754370008MICROLYZER FAT PROCESSOR 2400MC 3101MC 31012021-02-11
08682754370015MICROLYZER FAT PROCESSOR 1200MC 3102MC 31022021-02-11
08682754370022MICROLYZER Fat Processor 600MC 3103MC 31032021-02-11
08682754370039MICROLYZER Fat Processor 41MC 3104MC31042021-02-11
08681092003067MICROLYZERCARTRIDGEMCR12019-05-14
08681092003135MICROLYZERBLADE-FILTER 2400BLD24002019-05-14
08681092003142MICROLYZERBLADE-FILTER 1200BLD12002019-05-14
08681092003159MICROLYZERBLADE-FILTER 600BLD6002019-05-14

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Primary DI, Brand, Company table
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06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
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