FDA.reportPublic FDA data

Sanders Medical Products

Primary DI
00850055164000
Brand
Sanders Medical Products
Company
Sanders Medical Products, Inc.
Model
PET-CYLINDER
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYQPhantom, Flood Source, Nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYQPhantom, Flood Source, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055164000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055164000008500551640008500551640000850055164000

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine phantom, test objectA device that includes a wide variety of two or three-dimensional (3-D) phantoms used in both calibration protocols and in subjective and quantitative evaluations of the performance of diagnostic nuclear medicine (NM) detector systems, e.g., gamma cameras, single photon emission computed tomography (SPECT), positron emission tomography (PET) or associated image display system and software programs. It consists of either fixed or variable configurations or patterns of absorbing or attenuating materials and radioactive source holders. The design can incorporate radioactive sealed sources or refillable radioactive source wells to which radioactivity can be added.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(865)392-1505sandmed@sandersmedical.com

Regulatory Flags#

DUNS number
837530401
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055164017Sanders Medical ProductsPET-LINE2023-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810117210526Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210533Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210540Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210557Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
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00810117210601Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210618Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210625Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210632Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07