FDA.reportPublic FDA data

NA

Primary DI
00889024066717
Brand
NA
Company
Zimmer, Inc.
Model
3605
Catalog number
00-3605-000-00
Published
2016-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWOSKID, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWOSkid, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024066717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024066717008890240667178890240667170889024066717

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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
056038268
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
00889024711464Comp Mini Humeral Tray Trial Stem AdapterSSI008664SSI0086642026-08-25
008890247114712.9 JuggerKnot Self-Punching ObturatorSSI008672SSI0086722026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaSSI008671SSI0086712026-08-25
00889024712294Pin Target AssemblySSI001470SSI0014702026-08-25
00889024712300Z1 POSTERIOR HAMMR ADPTRSSI008666SSI0086662026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRSSI008665SSI0086652026-08-25
00889024712843PTH SHELL PSTNR ASSYSSI008611SSI0086112026-08-25
00889024712850PTH SHELL ADPTR SMLLSSI008612SSI0086122026-08-25
00889024712867PTH SHELL ADPTR LRGSSI008658SSI0086582026-08-25
00889024712874PTH BOOMSSI008680SSI0086802026-08-25
00889024712881PTH TROCARSSI008681SSI0086812026-08-25
008890247128986.5/8.0mm Countersink, Cannulated ZH QCSSI008697SSI0086972026-08-25
00889024712904RMR LONG KEYSSI008690SSI0086902026-08-25
00889024712911X BAR RMR ADPT TALLSSI008688SSI0086882026-08-25
00889024712928RMR SHORT KEYSSI008689SSI0086892026-08-25
00889024712935RMR SHORT KEY BENTSSI008691SSI0086912026-08-25
00889024712942RMR LONG KEY BENTSSI008692SSI0086922026-08-25
00889024713277Universal Uni Knee TensorSSI008695SSI0086952026-08-25
00889024713284Right Uni Knee TensorSSI008696SSI0086962026-08-25
00889024713291Left Uni Knee TensorSSI008694SSI0086942026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613124106MSI Precision Specialty InstrumentsMed Saver, Inc.HWO2025-08-01
G586N98822010Novo SurgicalNOVO SURGICAL, INC.HWO2023-12-18
07708604560205SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2023-01-18
07708604560359SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2023-01-18
00842331138850Novo Surgical Inc. NOVO SURGICAL, INC.HWO2022-11-11
07708604560014SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708604560106SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708626670159SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708626670777SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708626670906SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708604560038SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-09
00190776183660MillenniumAvalign Technologies, Inc.HWO2021-11-01
10381780183372Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
10381780433972Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
M2742254251Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
M2742254201Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
10381780427179Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-10
H834276800Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-10
00889024066724NAZimmer, Inc.HWO2017-05-09