FDA.reportPublic FDA data

New Style Thyroid Collar

Primary DI
G031611NSSRL0
Brand
New Style Thyroid Collar
Company
Shielding International Inc.
Model
611NSSRL
Device description
"New Style Thyroid Collar611NS Small - 22.5"" L - 0.5mm Reg Lead (RL)"
Published
2023-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G031611NSSRL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding collarA personal protective device intended to shield the neck area including the nape, the throat, and the thyroid of an individual (i.e., a device operator or other attending person) from unnecessary exposure to radiation during diagnostic or therapeutic medical and dental procedures. Collars used in x-ray and nuclear medicine typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Collars used for neutron attenuation are composed of hydrogenous materials instead of lead; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009647322
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G031QRSO2XFNL0Quick Release Skirt OnlyQRSO2XFNL2026-07-07
G031QRSO2XFRL0Quick Release Skirt OnlyQRSO2XFRL2026-07-07
G031QRSO2XFRLL0Quick Release Skirt OnlyQRSO2XFRLL2026-07-07
G031QRSO2XFTL0Quick Release Skirt OnlyQRSO2XFTL2026-07-07
G031QRSO2XMNL0Quick Release Skirt OnlyQRSO2XMNL2026-07-07
G031QRSO2XMRL0Quick Release Skirt OnlyQRSO2XMRL2026-07-07
G031QRSO2XMRLL0Quick Release Skirt OnlyQRSO2XMRLL2026-07-07
G031QRSO2XMTL0Quick Release Skirt OnlyQRSO2XMTL2026-07-07
G031QRSOLFRL0Quick Release Skirt OnlyQRSOXLMRLL2026-07-07
G031QRSOLMNL0Quick Release Skirt OnlyQRSOLMNL2026-07-07
G031QRSOLMRL0Quick Release Skirt OnlyQRSOLMRL2026-07-07
G031QRSOLMRLL0Quick Release Skirt OnlyQRSOLMRLL2026-07-07
G031QRSOLMTL0Quick Release Skirt OnlyQRSOLMTL2026-07-07
G031QRSOMFNL0Quick Release Skirt OnlyQRSOMFNL2026-07-07
G031QRSOMFTL0Quick Release Skirt OnlyQRSOSMTL2026-07-07
G031QRSOXLFNL0Quick Release Skirt OnlyQRSOXLFNL2026-07-07
G031QRSOXLFRL0Quick Release Skirt OnlyQRSOXLFRL2026-07-07
G031QRSOXLFRLL0Quick Release Skirt OnlyQRSOXLFRLL2026-07-07
G031QRSOXLFTL0Quick Release Skirt OnlyQRSOXLFTL2026-07-07
G031QRSOXLMNL0Quick Release Skirt OnlyQRSOXLMNL2026-07-07

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
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00748426261925Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
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00748426143511Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
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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
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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