FDA.reportPublic FDA data

Standard Imaging Seed Slider

Primary DI
00850019946031
Brand
Standard Imaging Seed Slider
Company
STANDARD IMAGING INC.
Model
90090
Catalog number
90090
Device description
Standard Imaging Seed Slider is designed for loading LDR Brachytherapy seeds and spacers into prostate needles.
Published
2023-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KPYShield, Protective, Personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019946031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019946031008500199460318500199460310850019946031

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding container, general-purposeA radiation protection device intended for hospital or clinic use that is specifically designed to shield persons from unintended radiation exposure to radioactive materials, sources, devices, and/or radiopharmaceuticals that are being kept in the facility. The design typically incorporates lead shielding or plastic materials of sufficient thickness to attenuate a specified level of radioactivity. This GMDN code does not include special purpose containers designed as vial or syringe shields or transportation/transfer containers.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
788084705
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019946543Standard Imaging IMSure 3D91365913652023-11-29
00850019946048Standard Imaging Needle Loading Shield90070900702023-06-22
00850019946062Standard Imaging Needle Cradle 90095900952023-06-22
00850019946079Standard Imaging CDX 2000B Electrometer90001900012023-06-22
00850019946086Standard Imaging MAX 4000 Plus Electrometer90020900202023-06-22
00850019946093Standard Imaging SuperMAX Electrometer90018900182023-06-22
00850019946109Standard Imaging MAX SD90030900302023-06-22
00850019946116Standard Imaging QA BeamChecker Plus90501905012023-06-22
00850019946123Standard Imaging QA StereoChecker91349913492023-06-22
00850019946130Standard Imaging Exradin Magna 60092600926002023-06-22
00850019946147Standard Imaging Exradin Magna 650 Ion Chamber92650926502023-06-22
00850019946154Standard Imaging Exradin A17 Ion Chamber92675926752023-06-22
00850019946161Standard Imaging Exradin A101 Ion Chamber92680926802023-06-22
00850019946178Standard Imaging Exradin A12 Ion Chamber92700927002023-06-22
00850019946185Standard Imaging Exradin A11 Ion Chamber92701927012023-06-22
00850019946192Standard Imaging Exradin A1 Ion Chamber92705927052023-06-22
00850019946208Standard Imaging Exradin A11TW Ion Chamber92708927082023-06-22
00850019946215Standard Imaging Exradin A14 Ion Chamber92711927112023-06-22
00850019946222Standard Imaging TomoElectrometer90016900162023-06-22
00850019946239Standard Imaging Exradin A4 Ion Chamber92715927152023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061871213IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871220IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871237IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871459IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
20748426261936Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
20748426261950Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261901Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261925Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
10748426143525Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143532Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143504Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143511Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143542Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143559Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143099Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143426Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143433Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143457Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143495Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143061Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143412Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143481Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426144280Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143078Medline-MicrotekMicrotek Medical LLCKPY2025-09-25
00748426143467DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-25
10748426143471DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
10748426144270DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426143443DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00816611026052Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30
00816611026069Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30