FDA.reportPublic FDA data

NA

Primary DI
00889024374904
Brand
NA
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
00-5049-089-00
Catalog number
00-5049-089-00
Published
2021-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDYEVACUATOR, VAPOR, CEMENT MONOMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDYEvacuator, Vapor, Cement MonomerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024374904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024374904008890243749048890243749040889024374904

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement fume evacuatorA mains electricity (AC-powered) portable device designed to filter out and/or evacuate the toxic fumes produced during the preparation of orthopaedic cement [e.g., polymethylmethacrylate (PMMA)] before they can reach the environment. The device is a small enclosure with filters that remove the toxic vapors, diffusing the filtered air in the environment, or that may be connected to the hospital exhaustion system. This device is used mainly in operating rooms and other hospital areas during orthopaedic procedures that involve bone cement preparation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
137354267
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024686120Oxford Surgical BladesOXF3PKXHUBOXF3PKXHUB2026-05-21
00889024686151Oxford Surgical BladesOXF3PKAES3OXF3PKAES32026-05-21
00889024686175Oxford Surgical BladesOXFKLSYKOXFKLSYK2026-05-21
00889024686083Oxford Surgical BladesOXF3PKLINVPOXF3PKLINVP2026-05-20
00889024686090Oxford Surgical BladesOXF3PKLINVVOXF3PKLINVV2026-05-20
00889024686106Oxford Surgical BladesOXF3PKSYKOXF3PKSYK2026-05-20
00889024686113Oxford Surgical BladesOXF3PKSYNOXF3PKSYN2026-05-20
00889024686137Oxford Surgical BladesOXF3PKZIMUOXF3PKZIMU2026-05-20
00889024686144Oxford Surgical BladesOXF3PKDESMOXF3PKDESM2026-05-20
00889024686168Oxford Surgical BladesOXFKLLINOXFKLLIN2026-05-20
00889024686182Oxford Surgical BladesOXFKLSYNOXFKLSYN2026-05-20
00889024686199Oxford Surgical BladesOXFKLZIMBOXFKLZIMB2026-05-20
00889024686205Oxford Surgical BladesOXFKLAESCOXFKLAESC2026-05-20
00889024375901Dermatome00-8801-001-0000-8801-001-002021-03-03
00889024464834Dermatome88710100887101002017-01-26
00889024626447A.T.S.® Personalized Pressure®60320010100603200101002023-08-30
00889024626454A.T.S.® Personalized Pressure®60-5000-101-00605000101002022-03-30
00889024375024PULSAVAC®00-5150-350-0000-5150-350-002016-08-12
00889024375031PULSAVAC®00-5150-350-0100-5150-350-012016-08-12
00889024375048PULSAVAC®00-5150-350-0200-5150-350-022016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842962102091HNM MEDICALHNM STAINLESS, LLC.JDY2023-05-27
00842962104309HNM MEDICALHNM STAINLESS, LLC.JDY2023-05-27
15060238200148SmartMix Vacuum Footpump and Airhose SUMMIT MEDICAL LIMITEDJDY2023-02-09
15060238200278Summit Medical High Vacuum Footpump + Air HoseSUMMIT MEDICAL LIMITEDJDY2023-02-09
15060238200452SmartMix CemVac Dual Vacuum Footpump & Airhose SUMMIT MEDICAL LIMITEDJDY2023-02-09
04260056881022EASYMIX® compressed air hoseOSARTIS GmbHJDY2022-12-01
04260056881039EASYMIX® compressed air hoseOSARTIS GmbHJDY2022-12-01
04260056881633EASYMIX® vacuum pump IOSARTIS GmbHJDY2022-12-01
04260056881930EASYMIX® vacuum pump IIOSARTIS GmbHJDY2022-12-01
04260102131231PALAMIX® Heraeus Medical GmbHJDY2019-05-15
00889024374867NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024374874NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024374881NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024374898NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024376670Miller™Zimmer, Inc.JDY2016-10-10
00889024382107Miller™Zimmer, Inc.JDY2016-10-10