FDA.reportPublic FDA data

NA

Primary DI
00889024277014
Brand
NA
Company
Zimmer GmbH
Model
00-8790-007-05
Catalog number
00-8790-007-05
Published
2020-06-30
Public version status
New
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
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024277014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024277014008890242770148890242770140889024277014

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
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
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

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00888867529830Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529847Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531628Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531635Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531680Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531727Arthrex®ARTHREX, INC.HWE2026-03-16
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09421038412169Offset drive train, lockingENZTEC LIMITEDHWE2026-03-09
09421038412176Short Offset Cover – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412183Handle – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412299Cup reamer handle, offset, AO, lockingENZTEC LIMITEDHWE2026-03-09
09421038412305Offset coupling, AOENZTEC LIMITEDHWE2026-03-09
09421038412312Cup reamer handle, offset, AO, openENZTEC LIMITEDHWE2026-03-09
09421038412329Offset drive train, openENZTEC LIMITEDHWE2026-03-09
09421038412671Cup reamer handle, offset, Z/H, openENZTEC LIMITEDHWE2026-03-09
00810111225601ReamerTreace Medical Concepts, Inc.HWE2026-03-02
00810111225618ReamerTreace Medical Concepts, Inc.HWE2026-03-02
00810111225625ReamerTreace Medical Concepts, Inc.HWE2026-03-02
09421038411865Enztec Modular OCI XENZTEC LIMITEDHWE2026-02-27
09421038412138Enztec Modular OCI XRENZTEC LIMITEDHWE2026-02-27
00888867536746Arthrex®ARTHREX, INC.HWE2026-02-25
00888867536760Arthrex®ARTHREX, INC.HWE2026-02-25
00888867536777Arthrex®ARTHREX, INC.HWE2026-02-25
09421038412725Enztec Reamer 36mm - BridgebackENZTEC LIMITEDHWE2026-02-23