FDA.reportPublic FDA data

Steradian Shield

Primary DI
00853714008080
Brand
Steradian Shield
Company
RADUX DEVICES, LLC
Model
SS0200
Catalog number
SS0200
Device description
Radiation Protection Shield
Published
2023-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPYShield, Protective, Personnel
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853714008087PackageGS110In Commercial Distribution
20853714008084PackageGS15In Commercial Distribution
00853714008080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085371400808710853714008087
2085371400808420853714008084
00853714008080008537140080808537140080800853714008080

GMDN Terms#

Term, Definition table
TermDefinition
Patient radiation shielding pad/drape, single-useA protective device intended to be placed on/draped over part of a patient’s body during a diagnostic or therapeutic radiological procedure to shield specific patient anatomies from unnecessary exposure to radiation and/or help block scatter radiation from the patient to protect healthcare workers. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material; it is not a piece of clothing such as an apron. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-935-3137hillari.jacobs@raduxdevices.com

Regulatory Flags#

DUNS number
079668796
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853714008011StandTallST0025LST0025L2019-08-16
00853714008028StandTallST0015LST0015L2019-08-16
00853714008004StandTallST0010LST0010L2019-08-16
00853714008103Steradian ShieldSS0300SS03002025-07-16
00853714008042LASSLP1002LP10022024-01-31
00853714008059LASSLP1001LP10012024-01-31
00853714008066LASSLP1003LP10032024-01-31
00853714008073LASSLP1004LP10042024-01-31
00853714008035Steradian ShieldSS0100SS01002019-09-25
10853714008087Steradian ShieldSS0200SS02002023-02-02
10853714008032Steradian ShieldSS0100SS01002019-09-25
10853714008018StandTallST0025LST0025L2019-08-16
10853714008025StandTallST0015LST0015L2019-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08684382977444SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382977451SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382999712SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
00850067913238SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913245SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913252SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913269SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913276SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913283SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913085SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913092SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913108SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913115SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913122SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913139SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913146SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913153SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913160SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913191SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913214SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913221SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00748426264575Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
10192253072211CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072228CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072235CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072242CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072259CONVERTORSCardinal Health 200, LLCPUI2026-10-14
20193489029946MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20748426264531Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20748426264593Medline-MicrotekMicrotek Medical LLCPUI2026-10-14