FDA.reportPublic FDA data

OPTIVAC FUSION

Primary DI
00880304488380
Brand
OPTIVAC FUSION
Company
BIOMET
Model
419000
Catalog number
419000
Published
2017-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00880304488380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304488380008803044883808803044883800880304488380

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement mixing bowlA sterile device designed for the specific purpose of containing the components that comprise orthopaedic bone cement while these are being mixed prior to application on a patient. It is typically used together with an orthopaedic cement mixer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+0330475759100eufrvra@zimmerbiomet.com

Regulatory Flags#

DUNS number
260930126
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
00880304810990Cement Delivery System1100306231100306232020-04-15
07350023771788Optigun Ratchet4195004195002020-05-23
07350023771719Cement Delivery System414641462021-04-27
03599870107898TESS BASEA1700380A17003802020-05-23
03599870108505T.E.S.S® LIDA1700382A17003822020-05-23
08428898898332TESS BOTTOM INSERT HEMIA1700384A17003842020-05-23
08428898898349TESS TOP INSERT HEMIA1700386A17003862020-05-23
00887868214578BIOMET® BONE CEMENT R1100353681100353682018-04-04
00887868214608BIOMET® BONE CEMENT R1100353711100353712018-04-04
07350023771092Optivac Nozzle Slim415441542019-10-11
07350023771108Optivac Nozzle Revision415541552017-10-09
07350023771214Knee Cementation Nozzle431243122017-10-09
07350023771429Angled Nozzle414941492017-10-09
00880304370326Right-Angle Nozzle4149004149002017-10-09
00880304370562Optivac Total Hip Kit4170004170002017-10-09
00880304370579Optivac Kit, 40 gram single Mix4171004171002017-10-09
00880304370609Optivac Kit, 80 gram Double Mix4172004172002017-10-09
00880304370623Optivac Kit, 120 gram Triple Mix4173004173002017-10-09
00880304370647Optivac Total Hip Kit4180004180002017-10-09
00880304370999Optivac Kit, 80 gram Double Mix4182004182002017-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONJDZ2024-11-21
07613327547535AutoPlex M4STRYKER CORPORATIONJDZ2024-11-21