FDA.reportPublic FDA data

PUREKIT Syringes

Primary DI
03701505801075
Brand
PUREKIT Syringes
Company
TEKNIMED
Model
T060426
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDZMixer, Cement, For Clinical Use
OARInjector, Vertebroplasty (Does Not Contain Cement)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701505801075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701505801075037015058010753701505801075

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
764746723
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760177040724CEMENTEK LVT8150LVT8150LV2015-10-16
03760177041080SINPLUS S800580052015-10-16
03760177041677KYPHON ACTIVOS 10C10AC10A2015-10-16
03760177042032MectaBone-P LV03,03,00303,03,0032015-10-16
03760177042384SPINE-FIX USUS040320SUS040320S2015-10-16
03760177042872ODONCER1000-2000µm 5ccT82102052015-10-16
03760177042889ODONCER1000-2000µm 2ccT82102022015-10-16
03760177042902ODONCER100-1000µm 5ccT82101052015-10-16
03760177042919ODONCER100-1000µm 2ccT82101022015-10-16
03760177043060ZVplastyVCF-1009VCF-10092015-10-16
03760177043923COHESIONCM0300CM03002015-10-16
03760177043930VERTEFIXVBC-100VBC-1002015-10-16
03760177043954VERTEMEND66-VMD-10066-VMD-1002015-10-16
03701505801204DynamoSpinal Cement – MV11-59202026-02-02
03760177040113OPACITY +T040320ZT040320Z2015-10-16
03760177041110F20T040520T0405202015-10-16
03760177041721HIGH V+T040321T0403212017-08-22
03760177042391EXOFIXT040323T0403232015-10-16
03701505800528Invictus® Bone Cement17095-1-S2023-02-17
03760177047174META +T0403522022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033737113813ADRIA srl - KIT OF 2 CEMENT INJECTION CANNULASADRIA SRLOAR2026-08-25
00840456203163JMUJMU DENTAL, INCJDZ2026-08-18
00840456207123JMUJMU DENTAL, INCJDZ2026-08-18
00840456207130JMUJMU DENTAL, INCJDZ2026-08-18
00840456223628JMUJMU DENTAL, INCJDZ2026-08-18
00840456223635JMUJMU DENTAL, INCJDZ2026-08-18
00840456223642JMUJMU DENTAL, INCJDZ2026-08-18
00840456223659JMUJMU DENTAL, INCJDZ2026-08-18
00840456223789JMUJMU DENTAL, INCJDZ2026-08-18
00840456223796JMUJMU DENTAL, INCJDZ2026-08-18
00840456223802JMUJMU DENTAL, INCJDZ2026-08-18
00884450587713StabiliT®Merit Medical Systems, Inc.OAR2026-07-30
D125705550R4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
D125705550W4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 GG21 SRLOAR2026-05-05
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAOAR2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAOAR2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAOAR2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAOAR2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAOAR2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAOAR2025-12-17
15060238201923Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
15060238201725Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201732Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201749HiVac BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201756Rally™ Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201787 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201794MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201886Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10
00884450837542StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20