FDA.reportPublic FDA data

"Adult Panoramic Apron .3mm 24"" X 27"""

Primary DI
00812045039293
Brand
"Adult Panoramic Apron .3mm 24"" X 27"""
Company
Flow X Ray Corporation
Model
75061-16
Device description
"Adult Panoramic Lead Apron .3mm 24"" X 27"" Medium Blue "
Published
2020-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWOApron, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWOApron, ProtectiveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812045039293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812045039293008120450392938120450392930812045039293

GMDN Terms#

Term, Definition table
TermDefinition
Patient radiation shielding pad/drape, reusableA protective device intended to be placed on/draped over part of a patient body (typically torso or chest) during a diagnostic or therapeutic radiological procedure, to shield specific patient anatomies from unnecessary exposure to radiation. 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010016319
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843696114312COMPRESSION PADDLE141072022-12-22
00081204503900DV-58 ADULT ECONO PAK182042023-08-09
00812045030115DX-58 ADULT PAPER PAK180012023-08-09
00812045030634DX-42 BITE CHEX180602023-08-09
00812045030832DV-57 ADULT TWIN VALUE PAK18201E2023-08-09
00812045030849DV-53 CHILD TWIN PEDO PAK18236E2023-08-09
00812045030856DSS-54 D CHILD SINGLE FILM BUTTERFLY PACKET19235E2023-08-09
00812045030863DSS-57 D ADULT SINGLE FILM BUTTERFLY PACKET19601E2023-08-09
00812045030870" DUPLICATING FILM, 14 X 17"""311762023-08-09
00812045030887DV-58 ADULT VALUE PAK182002023-08-09
00812045030894DV-57 ADULT TWIN VALUE PAK182012023-08-09
00812045030917DV-54 CHILD ECONO PAK182062023-08-09
00812045030924FV-58 ADULT ECONO PAK182152023-08-09
00812045030931DV-54 CHILD PEDO PAK182352023-08-09
00812045030948DV-53 CHILD TWIN PEDO PAK182362023-08-09
00812045030955FV-58 ADULT VALUE PAK183102023-08-09
00812045030962FV-57 ADULT TWIN VALUE PAK184102023-08-09
00812045030979DV-58 ADULT FRESH PAK186002023-08-09
00812045030986DV-57 ADULT TWIN FRESH PAK186012023-08-09
00812045030993FV-58 ADULT FRESH PAK186202023-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G031VBO2XFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13