FDA.reportPublic FDA data

AADCO

Primary DI
00840348526165
Brand
AADCO
Company
AADCO MEDICAL, INC.
Model
LP-207
Catalog number
LP-207
Device description
X-1 RADIATION RESISTANT GLOVES SIZE 6.5
Published
2022-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
EAJApron, Leaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAJApron, LeadedRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840348526165PrimaryGS10
00840348528336Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348526165008403485261658403485261650840348526165
00840348528336008403485283368403485283360840348528336

GMDN Terms#

Term, Definition table
TermDefinition
Partial-hand radiation shieldA flat pad with a strap or partial glove assembly used to shield only a portion of the hand or fingers of the wearer from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. Some types can be designed to shield just the palm, others may shield only the dorsal surface of the hand and fingers. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material and is typically intended to be worn over patient examination or surgical gloves.

Regulatory Flags#

DUNS number
153603204
Device count
5
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840348507690AADCOPB-505PB-5052022-12-14
00840348526493AADCON-640N-6402022-12-16
00840348526509AADCON-640DN-640D2022-12-16
00840348507409AADCOPB-200PB-2002022-12-07
00840348507416AADCOPB-201PB-2012022-12-07
00840348507454AADCOPB-206PB-2062022-12-07
00840348507461AADCOPB-207PB-2072022-12-07
00840348524185AADCOP-302P-3022022-12-07
00840348524192AADCOP-303P-3032022-12-07
00840348524208AADCOP-305P-3052022-12-07
00840348506396AADCOP-610P-6102022-12-14
00840348506402AADCOP-610CSP-610CS2022-12-14
00840348506419AADCOP-611P-6112022-12-14
00840348506426AADCOP-611CSP-611CS2022-12-14
00840348507997AADCOPBS-025PBS-0252022-12-14
00840348506259AADCOP-306P-3062022-12-07
00840348506709AADCOPB-121PB-1212022-12-07
00840348506716AADCOPB-121CPB-121C2022-12-07
00840348506723AADCOPB-122PB-1222022-12-07
00840348506730AADCOPB-122CPB-122C2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G031VBO2XFNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMMNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13