FDA.reportPublic FDA data

OsseoFit

Primary DI
00889024702707
Brand
OsseoFit
Company
Zimmer, Inc.
Model
00-5381-102-00
Catalog number
00-5381-102-00
Device description
Osseofit Shldr Prim Inst Tray
Published
2026-10-27
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
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
00889024702707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024702707008890247027078890247027070889024702707

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental 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 or inserts to hold 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)348-9500customerservice@zimmerbiomet.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
true
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
00889024702356OsseoFit00-5381-017-1100-5381-017-112026-10-28
00889024702363OsseoFit00-5381-017-1200-5381-017-122026-10-28
00889024702370OsseoFit00-5381-017-1300-5381-017-132026-10-28
00889024702387OsseoFit00-5381-017-1400-5381-017-142026-10-28
00889024702394OsseoFit00-5381-017-1500-5381-017-152026-10-28
00889024702400OsseoFit00-5381-017-1600-5381-017-162026-10-28
00889024702417OsseoFit00-5381-017-2100-5381-017-212026-10-28
00889024702424OsseoFit00-5381-017-2200-5381-017-222026-10-28
00889024702431OsseoFit00-5381-017-2300-5381-017-232026-10-28
00889024702448OsseoFit00-5381-017-2400-5381-017-242026-10-28
00889024702455OsseoFit00-5381-017-2500-5381-017-252026-10-28
00889024702462OsseoFit00-5381-017-2600-5381-017-262026-10-28
00889024702233OsseoFit00-5381-008-0500-5381-008-052026-10-27
00889024702240OsseoFit00-5381-008-0600-5381-008-062026-10-27
00889024702257OsseoFit00-5381-013-0000-5381-013-002026-10-27
00889024702264OsseoFit00-5381-013-1000-5381-013-102026-10-27
00889024702271OsseoFit00-5381-013-1100-5381-013-112026-10-27
00889024702295OsseoFit00-5381-013-1300-5381-013-132026-10-27
00889024702301OsseoFit00-5381-014-0000-5381-014-002026-10-27
00889024702318OsseoFit00-5381-014-0100-5381-014-012026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337122104iLESSYS® Delta Access TrayJoimax GmbHFSM2026-10-28
04250337122111iLESSYS® Delta Resection TrayJoimax GmbHFSM2026-10-28
06954454000564COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000571COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000588COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000595COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000601COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454001202COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454001271COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
M739223000700Nav Instruments General TrayCAPTIVA SPINE, INC.FSM2026-10-28
M739223000800Nav Instruments Pedicle Screws TrayCAPTIVA SPINE, INC.FSM2026-10-28
M739253001012Discectomy Prep TrayCAPTIVA SPINE, INC.FSM2026-10-28
00889024702660OsseoFitZimmer, Inc.FSM2026-10-27
00889024702677OsseoFitZimmer, Inc.FSM2026-10-27
00889024702684OsseoFitZimmer, Inc.FSM2026-10-27
00889024702691OsseoFitZimmer, Inc.FSM2026-10-27
00889024702714OsseoFitZimmer, Inc.FSM2026-10-27
04056481148232Sterilization Tray Accessories ENT/CMFBrainlab SEFSM2026-10-27
04056481148249Sterilization Tray Accessories Cranial (2 of 2)Brainlab SEFSM2026-10-27
04250337118497Vaporgrip® Bipo Sterilization TrayJoimax GmbHFSM2026-10-27
04250337119265TESSYS® Sterilization Tray for InstrumentsJoimax GmbHFSM2026-10-27
04250337119272TESSYS® Sterilization Tray for InstrumentsJoimax GmbHFSM2026-10-27
00889024699854IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699861IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699878IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699885IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699892IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699908IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699915Comprehensive HumeralZimmer, Inc.FSM2026-10-21
00889024699922Identity HumeralZimmer, Inc.FSM2026-10-21