FDA.reportPublic FDA data

Arm Sure Shield

Primary DI
09421902825934
Brand
Arm Sure Shield
Company
ADEPT MEDICAL LIMITED
Model
AM0630
Catalog number
AM0630
Device description
X-Ray Shield to ArmSure
Published
2018-05-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421902825934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421902825934094219028259349421902825934

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, portable/mobileA portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
592534619
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421901970345NeoZolineNZ3306NZ33062016-02-25
09421901970352NeoZolineNZ3306-2NZ3306-22016-02-25
09421901970369NeoZolineNZ3309NZ33092016-02-25
09421901970376NeoZolineNZ3309-2NZ3309-22016-02-25
09421901970383NeoZolineNZ3312NZ33122016-02-25
09421901970390NeoZolineNZ3312-2NZ3312-22016-02-25
09421901970406NeoZolineNZ3321NZ33212016-02-25
09421901970413NeoZolineNZ3321-2NZ3321-22016-02-25
09421905187770Adept Medical Retrograde IR Platform - Narrow + ExtensionAM0460AM04602026-02-09
09421905187787Adept Medical IR Platform Extension - NarrowAM0470AM04702026-02-09
09421902825927Arm StrapsAM0620AM06202018-05-24
09421902825491Adept Medical Femoral TableAM0300AM03002017-05-29
09421902825880IR ShieldAM0500AM05002017-11-24
09421902825941Adept Medical Drape SupportAM1000AM10002018-07-25
09421905187374Adept Medical ArmSureAM0640AM06402024-03-20
09421905187435Adept Medical STARTableDAM0140D2024-02-15
09421905187558Adept Medical Arm Support PadAAM01712022-10-13
09421905187589Adept Medical Drape SupportBAM1000B2022-10-13
09421902825712Adept Medical STARTableAM0140CAM0140C2017-05-29
09421902825347STARSupportAM0130AM01302018-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014205514TruBlu HDP BootlinersInfinitus Medical Technologies LLCCCX2026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05