FDA.reportPublic FDA data

COMPLETE DENTAL SUPPLIES

Primary DI
00850055627062
Brand
COMPLETE DENTAL SUPPLIES
Company
Complete Dental Supplies LLC
Model
20613-CDS
Device description
Isolation Gown, Nylon Knitted Cuffs 30g PP Blue 10 pcs/bag
Published
2023-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055627062PrimaryGS10
00850055627253Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055627062008500556270628500556270620850055627062
00850055627253008500556272538500556272530850055627253

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
054494926
Device count
10
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
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
00850055627390COMPLETE DENTAL SUPPLIES20547-CDS2023-09-22
00850055627413COMPLETE DENTAL SUPPLIES20458-CDS2023-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344158895MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158918MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158932MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158956MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158970MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158987MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344159014MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344159106MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
40080196247616MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
40080196730248MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
00688162000764ProtexterICP MEDICAL, LLCOEA2026-08-05
00840118617567Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617581Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617604Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617628Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617659ENDURE INDUSTRIESENDURE INDUSTRIESOEA2026-08-03
00840118617673Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617697Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617710Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617741Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617772Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617802Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118687690Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118698399Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
30193489103964MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489103971MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489104893MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489107969MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120241MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120258MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24