FDA.reportPublic FDA data

OPERON

Primary DI
07613327354300
Brand
OPERON
Company
STRYKER COMMUNICATIONS INC.
Model
OZ 7522875
Catalog number
OZ 7522875
Device description
Surgical Table, IMAGING EXTENSION FILLER PLATE
Published
2019-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDCTABLE, OPERATING-ROOM, ELECTRICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327354300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327354300076133273543007613327354300

GMDN Terms#

Term, Definition table
TermDefinition
Universal operating table, electrohydraulicA mobile, mains electricity (AC-powered) hydraulic-mechanism table designed to be adjusted to support a patient during many types of surgical interventions. The table surface consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface) to satisfy the requirements of many clinical specialties.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)726-3705SCC-CS2@stryker.com

Regulatory Flags#

DUNS number
078807493
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327394931OPERONOZ 7552475OZ 75524752019-01-24
07613327395037OPERONOZ 7552075OZ 75520752019-01-24
07613327395082OPERONOZ 7552275OZ 75522752019-01-24
07613327661194In-Light CameraP59109P591092025-08-27
07613327054507FLEXIS068240050006824005002023-06-07
07613327061178Visum BladeP22310P223102016-09-23
07613327054286NA068200028006820002802020-07-29
07613327054293NA068200028106820002812020-07-29
07613327166712NA068200085206820008522020-07-29
07613327166736NA068200085006820008502020-07-29
07613327589344OPERONOZ 7580275OZ 75802752022-03-22
07613327395068OPERONOZ 7561075OZ 75610752019-01-24
07613327395099OPERONOZ 7569075OZ 75690752019-01-24
07613327395136OPERONOZ 7568875OZ 75688752019-01-24
07613327054330Visum068200125206820012522016-09-23
07613327054347Visum068200125306820012532016-09-23
07613327054415Visum068240013706824001372016-09-23
07613327054422Visum068240013806824001382016-09-23
07613327061185Visum Blade, iSuiteP22309P223092016-09-30
07613327384505OPERONOZ 7559275OZ 75592752019-01-24

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00728564075004Assist Powered Medical Exam TableThe Brewer Company, LLCGDC2025-11-10
00810050245562NADOMICO MED-DEVICE, LLCGDC2025-09-24
00724995244880NASTERIS CORPORATIONGDC2025-05-05
00724995244965NASTERIS CORPORATIONGDC2025-05-05
00724995245030CMAX XRAY Remote ControlSTERIS CORPORATIONGDC2025-05-05
00887761966673Carbon Pelvic systemBaxter Medical Systems GmbH + Co. KGGDC2025-01-17
00857534006721Headboard AssemblyIMRIS Imaging, Inc.GDC2024-10-04
00887761967977Hillrom™Baxter Medical Systems GmbH + Co. KGGDC2024-02-22
00887761967984Hillrom™Baxter Medical Systems GmbH + Co. KGGDC2024-02-22
07285640070009Assist Powered Medical Exam TableThe Brewer Company, LLCGDC2023-10-10
07285640075004Assist Powered Medical Exam TableThe Brewer Company, LLCGDC2023-10-10
00887761967342Orthopedic ExtensionBaxter Medical Systems GmbH + Co. KGGDC2023-01-17
00887761967717Control UnitsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967731Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967748Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967762Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967793Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967809Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967816Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967823Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967830Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967847Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967854Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967861Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967878PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967892PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967908PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967922PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03