FDA.reportPublic FDA data

CLEANEST

Primary DI
06951233721672
Brand
CLEANEST
Company
Guangzhou Clean Medical Products Manufacturing Corp.
Model
CL006-06B1-02E
Catalog number
CL006-06B1-02E
Device description
Bone Cement Mixing System(Vacuum hose with spigot adapter) (Model No.: CL006-06B1)
Published
2024-05-15
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
06951233721672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06951233721672069512337216726951233721672

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic cement mixer, single-useA sterile hand-operated device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically consists of a vessel with attached/attachable mixing blades where the cement is mixed. It may include a plunger unit used to transfer the mixed cement from the vessel into an applicator prior to the surgical procedure, and a suction tube to enable connection to a separate fume extraction device. It is typically operated outside of the sterile surgical field and is not intended to contact the patient. This is a single-use device.

Regulatory Flags#

DUNS number
529707388
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
06951233720644EASYMIX® bowlLD2000LD20002022-12-12
06951233720842PALAGUN®CL006-02E(CM194)50823712025-06-05
06951233721610CLEANESTCL006-06A1-02ECL006-06A1-02E2024-05-15
06951233721634CLEANESTCL006-06A2-01ECL006-06A2-01E2024-05-15
06951233721658CLEANESTCL006-06A2-02ECL006-06A2-02E2024-05-15
06951233721665CLEANESTCL006-06B1-01ECL006-06B1-01E2024-05-15
06951233721696CLEANESTCL006-06B2-01ECL006-06B2-01E2024-05-15
06951233721719CLEANESTCL006-06B2-02ECL006-06B2-02E2024-05-15
06951233721726CLEANESTCL006-06C1-01ECL006-06C1-01E2024-05-15
06951233721733CLEANESTCL006-06C1-02ECL006-06C1-02E2024-05-15
06951233721757CLEANESTCL006-06C2-01ECL006-06C2-01E2024-05-15
06951233721771CLEANESTCL006-06C2-02ECL006-06C2-02E2024-05-15
06951233721788CLEANESTCL006-06-17ECL006-06-17E2024-05-15
06951233721795CLEANESTCL006-06-18ECL006-06-18E2024-05-15
06951233721603CLEANESTCL006-06A1-01ECL006-06A1-01E2024-05-13
04260102136038HeraeusCL006-01-18(CM194)50763732024-04-11
06951233720125CLEANESTW-202-B(EC)W-202-B(EC)2024-04-11
06951233720170CLEANESTW-202-P3(EC)W-202-P3(EC)2024-04-11
06951233720316CLEANESTW-202-P4(EC)W-202-P4(EC)2024-04-11
06951233720330CLEANESTW-202-P11(EC)W-202-P11(EC)2024-04-11

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
25060238201920Vacuum 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
15060238201787 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201794MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10