FDA.reportPublic FDA data

DG Health

Primary DI
10071031938539
Brand
DG Health
Company
DOLGENCORP, LLC
Model
QWC
Device description
Denture Adhesive, Original
Published
2020-08-31
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
KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-SodiumDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10071031938539PackageGS148Not in Commercial Distribution
00071031938532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007103193853910071031938539
00071031938532000710319385320710319385320071031938532

GMDN Terms#

Term, Definition table
TermDefinition
Carboxymethylcellulose sodium/polymer denture adhesive, zinc-freeAn adhesive compound composed of carboxymethylcellulose sodium and a polymer (e.g., ethylene oxide homopolymer, cationic polyacrylamide polymer, polyvinyl methylether maleic acid salt), that does not contain zinc (i.e., no zinc salts), intended to be used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068331990
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00017276224771Rexall0172762247712020-09-07
00834533001414DG HealthBDGGC362026-03-23
00834533001445DG HealthBDGGS182026-03-23
10834533001411DG HealthBDGGC362026-03-23
10834533001442DG HealthBDGGS182026-03-23
00751774000030DG Health20002256N/A2026-02-20
10751774000037DG Health20002256N/A2026-02-20
00751774242461Rexall One Step Pregnancy Test2020-07-10
00751774250473Rexall One Step Pregnancy Test2020-07-10
00197344018737RexallDG4335DG43352025-10-02
00751774260472Dollar GeneralOne Step Pregnancy Test2025-05-09
00751774262469DG HealthOne Step Pregnancy TestN/A2025-05-09
00845717090001Rexall77-35277-3522016-09-24
00845717773591Rexall77-35977-3592016-09-24
10751774260479Dollar GeneralOne Step Pregnancy Test2025-05-09
10751774262466DG HealthOne Step Pregnancy TestN/A2025-05-09
00646011887409Rexall Sterile Saline Wound Wash88-50740-200-002024-10-04
00197344110059RexallDG4345DG43452024-08-08
10197344110056RexallDG4345DG43452024-08-08
00751774250787DG healthOne Step Pregnancy TestN/A2023-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06943566100187Y-KelinANHUI GREENLAND BIOTECH CO.,LTDKOT2022-12-06
07506338303460Confident, MDC DentalMDC DENTALKOT2022-09-28
07506338303477Confident, MDC DentalMDC DENTALKOT2022-09-28
07506338303538Confident, MDC DentalMDC DENTALKOT2022-09-28
00032251004278Family WellnessFamily Dollar StoresKOT2020-09-21
00032251906169Family WellnessFamily Dollar StoresKOT2020-09-21
00071031517546RexallDOLGENCORP, LLCKOT2020-08-31
00071031518543RexallDOLGENCORP, LLCKOT2020-08-31
00071031938532DG HealthDOLGENCORP, LLCKOT2020-08-31
10071031517543RexallDOLGENCORP, LLCKOT2020-08-31
10071031518540RexallDOLGENCORP, LLCKOT2020-08-31
00857331000021DG HealthDOLGENCORP, LLCKOT2020-08-31