FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446138167
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
600-99-003
Device description
OPTIVAC MAX CAPACITY TRIPLE MIX (HIGH VOL CEMENT)
Published
2022-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
00190446138167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446138167001904461381671904461381670190446138167

GMDN Terms#

Term, Definition table
TermDefinition
Coated elbow humerus prosthesisA sterile implantable device designed to replace the distal humerus as part of an elbow joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154074504
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888912024983DJO SURGICAL520-38-0142017-08-07
00888912024990DJO SURGICAL520-38-0182017-08-07
00888912025003DJO SURGICAL520-38-1182017-08-07
00888912025010DJO SURGICAL520-42-0202017-08-07
00888912025027DJO SURGICAL520-42-1162017-08-07
00888912025034DJO SURGICAL520-46-1162017-08-07
00888912025041DJO SURGICAL520-46-1202017-08-07
00888912025058DJO SURGICAL520-50-1182017-08-07
00888912025065DJO SURGICAL520-50-1222017-08-07
00888912025072DJO SURGICAL520-50-1262017-08-07
00888912025089DJO SURGICAL520-54-1182017-08-07
00888912145114DJO SURGICAL520-42-0162017-08-07
00888912145138DJO SURGICAL520-42-1202017-08-07
00888912145145DJO SURGICAL520-46-0162017-08-07
00888912145152DJO SURGICAL520-46-0202017-08-07
00888912145169DJO SURGICAL520-46-0242017-08-07
00888912145190DJO SURGICAL520-46-1242017-08-07
00888912145206DJO SURGICAL520-50-0182017-08-07
00888912145213DJO SURGICAL520-50-0222017-08-07
00888912145220DJO SURGICAL520-50-0262017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
15060238201886Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10
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
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