FDA.reportPublic FDA data

Omni™ Surgical Suite Platform

Primary DI
00889024647343
Brand
Omni™ Surgical Suite Platform
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
AI1000
Catalog number
AI1000
Published
2023-01-17
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
OUGMedical device data system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024647343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024647343008890246473438890246473430889024647343

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].

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
137354267
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
00889024376014Tissue Bank Dermatome00-8831-000-1000-8831-000-102021-10-19
00889024375994Dermatome00-8821-001-0000-8821-001-002021-10-19
00889024376007Dermatome00-8821-006-0000-8821-006-002021-10-19
00889024376021Tissue Bank Dermatome00-8831-001-0000-8831-001-002021-10-18
00889024376038Tissue Bank Dermatome00-8831-003-002021-10-18
00889024553668NA00882100604008821006042019-02-13
00889024686120Oxford Surgical BladesOXF3PKXHUBOXF3PKXHUB2026-05-21
00889024686151Oxford Surgical BladesOXF3PKAES3OXF3PKAES32026-05-21
00889024686175Oxford Surgical BladesOXFKLSYKOXFKLSYK2026-05-21
00889024686083Oxford Surgical BladesOXF3PKLINVPOXF3PKLINVP2026-05-20
00889024686090Oxford Surgical BladesOXF3PKLINVVOXF3PKLINVV2026-05-20
00889024686106Oxford Surgical BladesOXF3PKSYKOXF3PKSYK2026-05-20
00889024686113Oxford Surgical BladesOXF3PKSYNOXF3PKSYN2026-05-20
00889024686137Oxford Surgical BladesOXF3PKZIMUOXF3PKZIMU2026-05-20
00889024686144Oxford Surgical BladesOXF3PKDESMOXF3PKDESM2026-05-20
00889024686168Oxford Surgical BladesOXFKLLINOXFKLLIN2026-05-20
00889024686182Oxford Surgical BladesOXFKLSYNOXFKLSYN2026-05-20
00889024686199Oxford Surgical BladesOXFKLZIMBOXFKLZIMB2026-05-20
00889024686205Oxford Surgical BladesOXFKLAESCOXFKLAESC2026-05-20
00889024375901Dermatome00-8801-001-0000-8801-001-002021-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONOUG2026-08-25
00850015699160Canary Flight PlanCanary Medical USA LLCOUG2026-08-07
00850015699177Canary Recovery CurveCanary Medical USA LLCOUG2026-08-07
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00763000292102N/AMEDTRONIC, INC.OUG2025-09-05
00841492105671ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105688ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105695ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105701ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105718ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105725ResponderRAULAND-BORG CORPORATIONOUG2025-06-24