FDA.reportPublic FDA data

NA

Primary DI
00724995153182
Brand
NA
Company
STERIS CORPORATION
Model
rShield
Catalog number
LB56
Device description
The STERIS Harmony rSheild is a radiation proton device with 23.6-inch tube mounts to the STERIS Lighting Visualization Systems.
Published
2021-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAKScreen, leaded, operator radiation protector
KPYShield, protective, personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAKScreen, Leaded, Operator Radiation ProtectorRadiology1
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995153182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995153182007249951531827249951531820724995153182

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, fixedA permanently installed device forming a structural barrier designed to block or attenuate radiation emissions from a primary or scattered radiation source. It includes various solid or transparent barriers typically used to shield patients from unnecessary exposure to radiation emitted from, e.g., diagnostic/therapeutic radiation emitting devices. It may also be used to shield a patient undergoing a diagnostic or therapeutic procedure requiring the administration of a radioactive material or placement of a radioactive source. The barrier can be permanently attached to the floor, wall or ceiling or to a medical device, or mounted on articulating structures giving a limited range of motion.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
036985604
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995234232V. MuellerCD14BCD14B2026-08-26
00724995234249V. MuellerCD14BBLACKCD14BBLACK2026-08-26
00724995234256V. MuellerCD14BBLUECD14BBLUE2026-08-26
00724995234263V. MuellerCD14BGOLDCD14BGOLD2026-08-26
00724995234270V. MuellerCD14BGREENCD14BGREEN2026-08-26
00724995234287V. MuellerCD14BPURPLECD14BPURPLE2026-08-26
00724995234294V. MuellerCD14BREDCD14BRED2026-08-26
00724995234300V. MuellerCD14CCD14C2026-08-26
00724995234317V. MuellerCD14CBLACKCD14CBLACK2026-08-26
00724995234324V. MuellerCD14CBLUECD14CBLUE2026-08-26
00724995234331V. MuellerCD14CGOLDCD14CGOLD2026-08-26
00724995234348V. MuellerCD14CGREENCD14CGREEN2026-08-26
00724995234355V. MuellerCD14CPURPLECD14CPURPLE2026-08-26
00724995234362V. MuellerCD14CREDCD14CRED2026-08-26
00724995234379V. MuellerCD15BCD15B2026-08-26
00724995234386V. MuellerCD15BBLACKCD15BBLACK2026-08-26
00724995234393V. MuellerCD15BBLUECD15BBLUE2026-08-26
00724995234409V. MuellerCD15BGOLDCD15BGOLD2026-08-26
00724995234416V. MuellerCD15BGREENCD15BGREEN2026-08-26
00724995234423V. MuellerCD15BPURPLECD15BPURPLE2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015605603Rampart Defender Radiation ShieldRampart Ic, LLCEAK2026-07-17
00860015605610Rampart VanguardRampart Ic, LLCEAK2026-07-17
05055449412483KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2026-06-04
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