FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813033302
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
5250738
Catalog number
5250738
Device description
CBCT Pano Cape Apron with Collar
Published
2020-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00889813033302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813033302008898130333028898130333020889813033302

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding apronA full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags#

DUNS number
825137818
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
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
00889813067994Darby Dental Supply, LLC525879552587952026-02-12
00889813068007Darby Dental Supply, LLC525879652587962026-02-12
00889813068021Darby Dental Supply, LLC525879752587972026-02-12
00889813068038Darby Dental Supply, LLC525879852587982026-02-12
00889813068045Darby Dental Supply, LLC525879952587992026-02-12
00889813068052Darby Dental Supply, LLC525879052587902026-02-12
00889813068069Darby Dental Supply, LLC525879152587912026-02-12
00889813068076Darby Dental Supply, LLC525879252587922026-02-12
00889813068083Darby Dental Supply, LLC525879352587932026-02-12
00889813068090Darby Dental Supply, LLC525879452587942026-02-12
00889813048566Darby Dental Supply, LLC943020394302032022-07-18
00889813048580Darby Dental Supply, LLC943020494302042022-07-18
00889813048610Darby Dental Supply, LLC943020594302052022-07-18
00889813048672Darby Dental Supply, LLC943021094302102022-07-18
00889813048696Darby Dental Supply, LLC943021194302112022-07-18
00889813048719Darby Dental Supply, LLC943021294302122022-07-18
00889813048443Darby Dental Supply, LLC943020294302022022-07-18
00889813048511Darby Dental Supply, LLC943020194302012022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G031QRSOMFRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOMMNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOMMRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOMMRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOMMTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSFNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSFRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSFRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSFTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSMNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSMTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSMRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-22
G031SO2XFRL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XFRLL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XFTL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XMNL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XMRL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XMRLL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XMTL0SkirtShielding International Inc.IWO2026-04-22
G031SOLFNL0SkirtShielding International Inc.IWO2026-04-22
G031SOLFRL0SkirtShielding International Inc.IWO2026-04-22
G031SOLFRLL0SkirtShielding International Inc.IWO2026-04-22
G031SOLFTL0SkirtShielding International Inc.IWO2026-04-22
G031SOLMNL0SkirtShielding International Inc.IWO2026-04-22
G031SOLMRL0SkirtShielding International Inc.IWO2026-04-22
G031SOLMRLL0SkirtShielding International Inc.IWO2026-04-22
G031SOLMTL0SkirtShielding International Inc.IWO2026-04-22
G031SOMFNL0SkirtShielding International Inc.IWO2026-04-22
G031SOMFRL0SkirtShielding International Inc.IWO2026-04-22
G031SOMFRLL0SkirtShielding International Inc.IWO2026-04-22