FDA.reportPublic FDA data

Cemex System Container

Primary DI
08031497002675
Brand
Cemex System Container
Company
TECRES SPA
Model
ASA0030
Device description
Cemex System Container is a container for Tecres' Cemex System that allows the mixing of Cemex System bone cement into Tecres' Cemex System Mixer.
Published
2022-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
08031497002675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031497002675080314970026758031497002675

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement sterile transfer container, single-useA device in which an orthopaedic cement dispenser is intended to be placed to maintain the sterility of the dispenser and its contents (orthopaedic cement) when it is taken out of the sterile field to be mixed by an automatic mixer during a surgical procedure. It is typically made of plastic material and designed to be passed by operating staff from the sterile field to staff who may not be sterile, and back again, without compromising the sterility of its contents. This is a single-use device.

Regulatory Flags#

DUNS number
435428396
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
080314970020572Mix GunASA03102024-02-12
08031497002187GUN-01GUN-012022-09-23
08031497002330RALLY All In One Cement Gun712716102022-09-23
08031497002538Kyphon VuE™ Bone CementCT01A2022-05-13
08031497002095Conflow Bone Cement1100430252021-06-09
08031497002101Conflow G Bone Cement1100430262021-06-09
08031497002118MectaCem-X LV65.01.1032021-06-09
08031497002125MectaCem-X HV65.01.1012021-06-09
08031497002149MectaCem-X LV with Gentamicin65.01.113US2021-06-09
08031497002163MectaCem-X HV with Gentamicin65.01.111US2021-06-09
28031497000019Cemex RX1200/A2015-10-08
28031497000033CEMEX ISOPLASTIC1200/I2015-10-08
28031497000057CEMEX XL1200/S2015-10-08
28031497000071CEMEX ISOPLASTIC 1/2 PACK1220/I2015-10-08
28031497000101Mendec Spine12302015-10-06
28031497000491Cemex Genta LV1400/AG US2015-10-06
28031497000507Cemex Genta HV1400/IG US2015-10-06
08031497003894InterSpace Hip Trial, 46mm ShortIHT46S2026-02-11
08031497003900InterSpace Hip Trial, 54mm ShortIHT54S2026-02-11
08031497003917InterSpace Hip Trial, 60mm ShortIHT60S2026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
D125705550R4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
D125705550W4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
06934415056632ZKSKBeijing ZKSK Technology Co.,LtdJDZ2026-05-18
06934415056649ZKSKBeijing ZKSK Technology Co.,LtdJDZ2026-05-18
04250203943482QuattroMixJoline GmbH & Co. KGJDZ2026-03-03
03701505801211DynamoTEKNIMEDJDZ2026-02-02
03701505801228DynamoTEKNIMEDJDZ2026-02-02
03701505801235DynamoTEKNIMEDJDZ2026-02-02
15060238201923Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
03701505801020PureKit Syringe 1.5cc MVTEKNIMEDJDZ2025-03-31
03701505801037META+ System 1.5cc MVTEKNIMEDJDZ2025-03-31
03701505801075PUREKIT SyringesTEKNIMEDJDZ2025-03-31
03701505800498PureKit Syringe 4cc MVTEKNIMEDJDZ2025-03-31
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
15060238201787MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201794MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201886Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10