FDA.reportPublic FDA data

Amplifine

Primary DI
00350224000158
Brand
Amplifine
Company
SUNEVA MEDICAL, INC.
Model
BD Vacutainer and Torniquet
Catalog number
SM-PRP-VT-10
Device description
Amplifine HD PRP convenience kit.Collection Set & Tourniquet, 10 pack
Published
2022-02-10
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
ORGPlatelet And Plasma Separator For Bone Graft Handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00350224000158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00350224000158003502240001583502240001580350224000158

GMDN Terms#

Term, Definition table
TermDefinition
Autologous blood collection tubeA sterile vacuum tube intended to be used for the collection of venous blood and production of autologous platelet rich fibrin (PRF) for mixing with bone graft to repair bone defects in the patient from whom the blood is derived. It typically contains a clot activator (e.g., silica) to facilitate isolation of the PRF, and has features that enable its use in a centrifuge. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858-550-9999customersupport@sunevamedical.com

Regulatory Flags#

DUNS number
012844615
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350224000035SKIN TEST0.3ccGBS05012019-03-19
00350224000141BELLAFILL1.5 ccGBF0115, GBF0215, GBF03152022-09-13
00350224000004ARTEFILL 8021 AF0508 2014-09-24
00350224000028BELLAFILL1.0 ccGBF0208, GBF05082014-12-01
00350224000103Amplifine15mlSM-PRP-152020-12-31
00350224000110Amplifine30mlSM-PRP-302020-12-31
00350224000165AmplifineBD Large Holder VacutainerSM-PRP-LV-102022-02-10
00350224000127Amplifine15ml - BDSM-PRP-15-BD2020-12-31
00350224000134Amplifine30ml - BDSM-PRP-30-BD2020-12-31
10350224000148BELLAFILL1.5 ccGBF0115, GBF0215, GBF03152022-09-13
10350224000100Amplifine15mlSM-PRP-152020-12-31
10350224000117Amplifine30mlSM-PRP-302020-12-31
10350224000032SKIN TEST0.3ccGBS05012019-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719875912276Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2026-06-22
08685139210029Centrifuge Container SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-04-10
00850083564001MARGENIXBahia Medical Inc.ORG2026-04-03
00850083564025MARGENIXBahia Medical Inc.ORG2026-04-03
00850083564049GoldrushBahia Medical Inc.ORG2026-04-03
00850083564056GoldrushBahia Medical Inc.ORG2026-04-03
00850083564063GenesisBahia Medical Inc.ORG2026-04-03
00850023741561CERVOS PLATELET SEPARATOR 80 KITRANFAC CORP.ORG2026-03-30
00850075308088CER-PRP-160 STERILITY PACKRANFAC CORP.ORG2026-03-30
00850075308101CER-PRP-160 KitRANFAC CORP.ORG2026-03-30
00850075308163CER-PRP-40 KIT F/G, STERILERANFAC CORP.ORG2026-03-30
B708XCPC120XCELLAPEX BIOLOGIX , LLCORG2026-03-26
B708XCPC60XCELLAPEX BIOLOGIX , LLCORG2026-03-26
00850033131215RegenKit®-BCT-T-URegenlab USA LLCORG2026-03-25
08685139210036Exocube SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210012ExoCubeEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210067ExoCube-20PackEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08809410200046Dr.PRPRmedica Co.,LtdORG2026-02-02
08809410200053Dr.PRPRmedica Co.,LtdORG2026-02-02
G668FG0010ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
G668FG0011ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFIDIA FARMACEUTICI SPAORG2025-10-31
00850075308095CER-PRP-SINGLE-ARANFAC CORP.ORG2025-10-08
04719875912245Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
04719875912252Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912242Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912259Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
00850075308118Cervos Platelet Separator Triple Pack B2RANFAC CORP.ORG2025-07-23
10850075308115Cervos Platelet Separator Triple Pack B2RANFAC CORP.ORG2025-07-23
08435389829089ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-06-03