FDA.reportPublic FDA data

Miller™

Primary DI
00889024382107
Brand
Miller™
Company
Zimmer, Inc.
Model
5069-52
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
00889024379800PackageGS110In Commercial Distribution
00889024382107PackageGS15In Commercial Distribution
00889024376670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024379800008890243798008890243798000889024379800
00889024382107008890243821078890243821070889024382107
00889024376670008890243766708890243766700889024376670

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
056038268
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
00889024701670Identity® Shoulder System1200046571200046572026-06-09
00889024707382Persona Tensor Sizer Arm – LongSSI008513SSI0085132026-05-29
00889024707399Persona Tensor Sizer Arm – StdSSI008567SSI0085672026-05-29
00889024707405Persona Tensor Sizer BodySSI008566SSI0085662026-05-29
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28

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
00889024374904NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2021-03-03
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