FDA.reportPublic FDA data

EASY KIT M

Primary DI
03760177042117
Brand
EASY KIT M
Company
TEKNIMED
Model
T060415
Catalog number
T060415
Published
2020-09-24
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760177042117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177042117037601770421173760177042117

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
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701505801204DynamoSpinal Cement – MV11-59202026-02-02
03701505801211Dynamo Spinal Cement System Syringe MV 1.5cc11-59212026-02-02
03701505801228DynamoSpinal Cement System Syringe MV 4cc11-59222026-02-02
03701505801235DynamoSpinal Cement System Gun MV11-59232026-02-02
03760177044326Signature -x Cement SVP/N191-14-40002026-01-23
03760177044333Signature -x Cement LVP/N191-14-40012026-01-23
03760177044340Signature -x Cement MVMVP/N191-14-40022026-01-23
03760177040090GENTAFIX1T040140G2025-09-02
03760177040137GENTAFIX3T040340G2025-09-02
03760177043176GENTAFIX3 MVT040341G2025-09-02
03760177042698Euroscrew NGØ6 L20T720620NG2023-12-18
03760177042704Euroscrew NGØ7 L24T720724NG2023-12-18
03760177042711Euroscrew NGØ7 L30T720730NG2023-12-18
03760177042728Euroscrew NGØ8 L24T720824NG2023-12-18
03760177042735Euroscrew NGØ9 L24T720924NG2023-12-18
03760177042742Euroscrew NGØ8 L30T720830NG2023-12-18
03760177042759Euroscrew NGØ9 L30T720930NG2023-12-18
03760177042766Euroscrew NGØ10 L30T721030NG2023-12-18
03760177042773Euroscrew NGØ11 L35T721135NG2023-12-18
03760177042780Euroscrew TCP NGØ06 L20T730620NG2023-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250203943482QuattroMixJoline GmbH & Co. KGJDZ2026-03-03
25060238201920Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
25060238201722Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201739Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201746HiVac BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201753Rally™ Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201784 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201791MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201883Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONJDZ2024-11-21
07613327547535AutoPlex M4STRYKER CORPORATIONJDZ2024-11-21
08058964723758Disp. Mixing Bowl-OG21 SRLJDZ2024-10-14
08058964728654Arthrex Bone Cement Mixing Syringe G21 SRLJDZ2024-10-14
08058964728715Arthrex Bone Cement Open Mixing BowlG21 SRLJDZ2024-10-14
08058964728753Arthrex Bone Cement Closed Mixing Bowl G21 SRLJDZ2024-10-14
08058964729057Arthrex Bone Cement Closed Mixing Bowl G21 SRLJDZ2024-10-14
08058964729064Arthrex Bone Cement Mixing Syringe G21 SRLJDZ2024-10-14
08058964724564PicoMix VG21 SRLJDZ2024-10-10
08058964724670PicoMix BowlG21 SRLJDZ2024-10-10
08058964725042PicoMix SyringeG21 SRLJDZ2024-10-10
08058964726261PicoMix SyringeG21 SRLJDZ2024-10-10
08058964727831PicoMix BowlG21 SRLJDZ2024-10-10
08058964727848PicoMix SyringeG21 SRLJDZ2024-10-10
06951233721610CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721634CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721658CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721665CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721672CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721696CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721719CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15