FDA.reportPublic FDA data

NA

Primary DI
00889024355217
Brand
NA
Company
Zimmer Surgical SA
Model
89-8510-459-42
Catalog number
89-8510-459-42
Published
2016-05-16
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024355217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024355217008890243552178890243552170889024355217

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. 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@zimmer.com

Regulatory Flags#

DUNS number
481290781
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
00889024687462Zimmer Biomet®1100462981100462982025-04-01
00889024355163Zimmer Biomet™89-8510-440-3089-8510-440-302022-06-10
00889024581746Zimmer Biomet™89-8521-470-4089-8521-470-402020-09-03
00889024355149Zimmer Biomet™89-8510-440-1089-8510-440-102016-05-16
00889024521117Zimmer Biomet™ X Series Power System8985204000089-8520-400-002020-09-03
00889024521124Zimmer Biomet™ X Series Power System8985204001089-8520-400-102020-09-03
00889024354593Zimmer® Universal Power System8985074000089-8507-400-002016-05-16
00889024354609Zimmer® Universal Power System8985074001089-8507-400-102016-05-16
00889024581760Zimmer Biomet™89-8521-470-8089-8521-470-802022-12-16
00887868572890Zimmer Biomet®89-8522-150-7089-8522-150-702023-09-28
00887868572906Zimmer Biomet®89-8522-270-7089-8522-270-702023-09-28
00887868572913Zimmer Biomet®89-8522-600-7089-8522-600-702023-09-28
00889024521100Zimmer Biomet™89-8521-470-7089-8521-470-702022-12-16
00889024490109Zimmer Biomet™89-8509-451-4689-8509-451-462022-06-10
00889024521339Zimmer Biomet™89-8522-451-4289-8522-451-422020-09-03
00889024521346Zimmer Biomet™89-8522-451-4389-8522-451-432020-09-03
00889024354951Zimmer Biomet™89-8509-451-4189-8509-451-412016-05-16
00889024421530Zimmer Biomet™89-8509-451-4289-8509-451-422016-05-16
00889024421547Zimmer Biomet™89-8509-451-4389-8509-451-432016-05-16
00889024581722Zimmer Biomet™89-8521-470-2089-8521-470-202020-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024699939N/AZimmer, Inc.FSM2026-10-20
00889024699946N/AZimmer, Inc.FSM2026-10-20
00889024699953Alliance Glenoid, Identity HumeralZimmer, Inc.FSM2026-10-20
00810111228428Instrument TrayTreace Medical Concepts, Inc.FSM2026-10-16
00810161900909EARP IMPLANT TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900916EARP INSTRUMENT TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900923EARP INSTRUMENT AND IMPLANT LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900930EARP RETRACTOR TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900947EARP RETRACTOR LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900954EARP, TRIAL CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900961EARP, TRIAL LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900978EARP, DISC SPACER CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900985EARP, DISC SPACER LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901746EARP INSTRUMENT #2 TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901753EARP INSTRUMENT #2 LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901814EARP, PLATFORM CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901821EARP, PLATFORM LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
04042409457203CHBSaap Implantate AGFSM2026-10-16
04042409457289CHBSaap Implantate AGFSM2026-10-16
04042409457302CHBSaap Implantate AGFSM2026-10-16
04042409457326CHBSaap Implantate AGFSM2026-10-16
04042409457340CHBSaap Implantate AGFSM2026-10-16
05055662966855Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-10-16
05055662966862Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-10-16
00724995239992V. MuellerSteris CorporationFSM2026-10-15
00724995240004V. MuellerSteris CorporationFSM2026-10-15
00724995240011V. MuellerSteris CorporationFSM2026-10-15
00724995240028V. MuellerSteris CorporationFSM2026-10-15
00724995243401V. MuellerSteris CorporationFSM2026-10-15
00889795150271APEX 3D Total Ankle Replacement SystemParagon 28, Inc.FSM2026-10-12