FDA.reportPublic FDA data

OrthoGrid®

Primary DI
00889024707443
Brand
OrthoGrid®
Company
Orthogrid Systems, Inc.
Model
20-8025-110-00
Device description
9-Inch Calibration Array
Published
2026-07-15
Public version status
Update
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
LHOInstrument, Quality-Assurance, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHOInstrument, Quality-Assurance, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024707443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024707443008890247074438890247074430889024707443

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic test patternA device designed to provide a test pattern appropriate for measuring, calibration, and quality control of radiographic and/or fluoroscopic systems and/or associated equipment (e.g., image intensifiers and video systems) during radiographic procedures. It typically consists of metallic screens (e.g., lead-foil, copper mesh, gold-nickel alloys) frequently sandwiched between two plastic plates; the choice of the pattern configuration, either linear or circular, and its other characteristics, depends on the particular measurement to be performed (e.g., focal spot size, resolution, modulation transfer function). The test pattern may be available in digital signal format (e.g., DVD).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0

Contacts#

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

Regulatory Flags#

DUNS number
079674160
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707092OrthoGrid®20-8025-500-002026-07-15
00889024707450OrthoGrid®20-8025-210-002026-07-15
00860003424841OrthoGrid Hip Trauma2010-915-5072025-06-24
00860003424858Orthogrid Calibration Array1020-915-1232025-06-24
00860003424865Orthogrid Calibration Array1020-915-1242025-06-24
00860003424834OrthoGrid Hip AI1015-915-5052022-05-19
00860003424827OrthoGrid Hip Trauma2010-915-5022021-08-27
00860003424803OrthoGrid Hip1015-915-5042021-03-05
00860003424810OrthoGrid Hip Preservation4015-915-5012021-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04995047069485RadiCSEIZO CORPORATIONLHO2026-09-04
04995047071655RadiCSEIZO CORPORATIONLHO2026-09-04
04995047071662RadiCSEIZO CORPORATIONLHO2026-09-04
00889024707450OrthoGrid®Orthogrid Systems, Inc.LHO2026-07-15
05060608881499RapidCHECKSUN NUCLEAR CORP.LHO2026-05-10
EIBAE30635000myQA StarTrack³, including Energy Verification Plates and SoftwareIBA Dosimetry GmbHLHO2026-04-24
EPTWT20020Q1Q1000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q1100COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q1300COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q2000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q3000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q3100COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q4000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41018Q1Q0100MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41018Q1Q0120MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0040MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0050MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0060MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0070MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0120MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT410250MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT410330MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT410520MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT110620DIAMENTORPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT110640DIAMENTORPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT296720RW3 slab phantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT29672JU100RW3 slab phantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT29672JU140RW3 slab phantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT29672JU150RW3 slab phantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT29672JU190RW3 slab phantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15