FDA.reportPublic FDA data

COMPLETE DENTAL SUPPLIES

Primary DI
00850055627390
Brand
COMPLETE DENTAL SUPPLIES
Company
Complete Dental Supplies LLC
Model
20547-CDS
Device description
Self Sealing Sterilization Pouches, China paper, with 4 indicators, Steam and EO Indicator with internal and external indicators 7.25"*13",190x(330+30)mm 200 pcs/box
Published
2023-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00850055627383PrimaryGS10
00850055627390Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055627383008500556273838500556273830850055627383
00850055627390008500556273908500556273900850055627390

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054494926
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055627000COMPLETE DENTAL SUPPLIES20460-CDS2023-09-06
00850055627154COMPLETE DENTAL SUPPLIES20468-CDS2023-09-06
00850055627406COMPLETE DENTAL SUPPLIES20458-CDS2023-09-22
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
00850055627413COMPLETE DENTAL SUPPLIES20458-CDS2023-09-22
00850055627437COMPLETE DENTAL SUPPLIES20367-CDS2023-09-22

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Primary DI, Brand, Company table
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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
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