FDA.reportPublic FDA data

Comfort Fit Thyroid Collar

Primary DI
G031641CFSRL0
Brand
Comfort Fit Thyroid Collar
Company
Shielding International Inc.
Model
641CFSRL
Device description
"Comfort Fit Thyroid Collar641CF Small - 24"" 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
G031641CFSRL0PrimaryHIBCC0

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
G031QRSOMFRL0Quick Release Skirt OnlyQRSOMFRL2026-04-28
G031QRSOMMNL0Quick Release Skirt OnlyQRSOMMNL2026-04-28
G031QRSOMMRL0Quick Release Skirt OnlyQRSOMMRL2026-04-28
G031QRSOMMRLL0Quick Release Skirt OnlyQRSOMMRLL2026-04-28
G031QRSOMMTL0Quick Release Skirt OnlyQRSOMMTL2026-04-28
G031QRSOSFNL0Quick Release Skirt OnlyQRSOSFNL2026-04-28
G031QRSOSFRL0Quick Release Skirt OnlyQRSOSFRL2026-04-28
G031QRSOSFRLL0Quick Release Skirt OnlyQRSOSFRLL2026-04-28
G031QRSOSFTL0Quick Release Skirt OnlyQRSOSFTL2026-04-28
G031QRSOSMNL0Quick Release Skirt OnlyQRSOSMNL2026-04-28
G031QRSOSMTL0Quick Release Skirt OnlyQRSOSMTL2026-04-28
G031QRSOSMRLL0Quick Release Skirt OnlyQRSOSMRLL2026-04-22
G031SO2XFRL0SkirtSO2XFRL2026-04-22
G031SO2XFRLL0SkirtSO2XFRLL2026-04-22
G031SO2XFTL0SkirtSO2XFTL2026-04-22
G031SO2XMNL0SkirtSO2XMNL2026-04-22
G031SO2XMRL0SkirtSO2XMRL2026-04-22
G031SO2XMRLL0SkirtSO2XMRLL2026-04-22
G031SO2XMTL0SkirtSO2XMTL2026-04-22
G031SOLFNL0SkirtSOLFNL2026-04-22

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