FDA.reportPublic FDA data

COMPLETE DENTAL SUPPLIES

Primary DI
00850055627406
Brand
COMPLETE DENTAL SUPPLIES
Company
Complete Dental Supplies LLC
Model
20458-CDS
Device description
"Tray Sleeves 10-1.2""x14"" 267mmX335mm 500 pcs/box"
Published
2023-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055627406PrimaryGS10
00850055627413Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055627406008500556274068500556274060850055627406
00850055627413008500556274138500556274130850055627413

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
054494926
Device count
500
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055627000COMPLETE DENTAL SUPPLIES20460-CDS2023-09-06
00850055627154COMPLETE DENTAL SUPPLIES20468-CDS2023-09-06
00850055627581COMPLETE DENTAL SUPPLIES20374-CDS2023-09-25
00850055627598COMPLETE DENTAL SUPPLIES20374-CDS2023-09-25
00850055627147COMPLETE DENTAL SUPPLIES20470-CDS2023-09-22
00850055627178COMPLETE DENTAL SUPPLIES20465-CDS2023-09-22
00850055627383COMPLETE DENTAL SUPPLIES20547-CDS2023-09-22
00850055627420COMPLETE DENTAL SUPPLIES20367-CDS2023-09-22
00850055627444COMPLETE DENTAL SUPPLIES20368-CDS2023-09-22
00850055627468COMPLETE DENTAL SUPPLIES20472-CDS2023-09-22
00850055627482COMPLETE DENTAL SUPPLIES20473-CDS2023-09-22
00850055627505COMPLETE DENTAL SUPPLIES20474-CDS2023-09-22
00850055627529COMPLETE DENTAL SUPPLIES20475-CDS2023-09-22
00850055627543COMPLETE DENTAL SUPPLIES20476-CDS2023-09-22
00850055627567COMPLETE DENTAL SUPPLIES20477-CDS2023-09-22
00850055627369COMPLETE DENTAL SUPPLIES20470-CDS2023-09-22
00850055627376COMPLETE DENTAL SUPPLIES20465-CDS2023-09-22
00850055627390COMPLETE DENTAL SUPPLIES20547-CDS2023-09-22
00850055627413COMPLETE DENTAL SUPPLIES20458-CDS2023-09-22
00850055627437COMPLETE DENTAL SUPPLIES20367-CDS2023-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10371347017929Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017837Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017844Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017851Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017868Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
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