FDA.reportPublic FDA data

NA

Primary DI
00889024288669
Brand
NA
Company
Zimmer GmbH
Model
01.06808.300
Catalog number
01.06808.300
Published
2020-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWAIMPACTOR
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024288669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024288669008890242886698890242886690889024288669

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

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
488133448
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024292512NCB®02.02261.0132024-05-03
00889024292550NCB®02.02261.1132024-05-03
00889024296558NCB®02.03156.0902024-05-03
00889024296565NCB®02.03156.0952024-05-03
00889024296572NCB®02.03156.1002024-05-03
00889024593152Wagner Cone Prosthesis®01.00561.31301.00561.3132022-12-13
00889024593176Wagner Cone Prosthesis®01.00561.21501.00561.2152022-12-13
00889024593183Wagner Cone Prosthesis®01.00561.21601.00561.2162022-12-13
00889024593190Wagner Cone Prosthesis®01.00561.21701.00561.2172022-12-13
00889024593206Wagner Cone Prosthesis®01.00561.31401.00561.3142022-12-13
00889024593213Wagner Cone Prosthesis®01.00561.21801.00561.2182022-12-13
00889024593237Wagner Cone Prosthesis®01.00561.21901.00561.2192022-12-13
00889024593251Wagner Cone Prosthesis®01.00561.31701.00561.3172022-12-13
00889024593268Wagner Cone Prosthesis®01.00561.31801.00561.3182022-12-13
00889024593534Wagner SL Revision®01.00102.62401.00102.6242022-12-13
00889024593541Wagner SL Revision®01.00102.62501.00102.6252022-12-13
00889024593145Wagner Cone Prosthesis®01.00561.21301.00561.2132022-12-13
00889024593169Wagner Cone Prosthesis®01.00561.21401.00561.2142022-12-13
00889024593220Wagner Cone Prosthesis®01.00561.31501.00561.3152022-12-13
00889024593244Wagner Cone Prosthesis®01.00561.31601.00561.3162022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048844693367implaFit®implantcast GmbHLZO2026-03-26
04048844693411implaFit®implantcast GmbHLZO2026-03-26
04048844693442implaFit®implantcast GmbHLZO2026-03-26
04048844693510implaFit®implantcast GmbHLZO2026-03-26
04048844693565implaFit®implantcast GmbHLZO2026-03-26
04048844693596implaFit®implantcast GmbHLZO2026-03-26
04048844731977implaFit®implantcast GmbHLZO2026-03-20
04048844732042implaFit®implantcast GmbHLZO2026-03-20
04048844732059implaFit®implantcast GmbHLZO2026-03-20
04048844732080implaFit®implantcast GmbHLZO2026-03-20
04048844732097implaFit®implantcast GmbHLZO2026-03-20
10885862648150EquinoxeExactech, Inc.HWA2026-03-19
10885862660145N/AExactech, Inc.LZO2026-03-19
10885862660152N/AExactech, Inc.LZO2026-03-19
10885862660169N/AExactech, Inc.LZO2026-03-19
10885862660176N/AExactech, Inc.LZO2026-03-19
10885862660183N/AExactech, Inc.LZO2026-03-19
10885862660190N/AExactech, Inc.LZO2026-03-19
10885862660206N/AExactech, Inc.LZO2026-03-19
10885862660213N/AExactech, Inc.LZO2026-03-19
10885862660220N/AExactech, Inc.LZO2026-03-19
10885862660237N/AExactech, Inc.LZO2026-03-19
10885862660244N/AExactech, Inc.LZO2026-03-19
10885862660251N/AExactech, Inc.LZO2026-03-19
10885862660268N/AExactech, Inc.LZO2026-03-19
10885862660275N/AExactech, Inc.LZO2026-03-19
10885862660282N/AExactech, Inc.LZO2026-03-19
10885862660299N/AExactech, Inc.LZO2026-03-19
10885862660305N/AExactech, Inc.LZO2026-03-19
10885862660312N/AExactech, Inc.LZO2026-03-19