FDA.reportPublic FDA data

Cora

Primary DI
00850373007041
Brand
Cora
Company
Cora
Model
02Tampons-105
Device description
Cora Tampons, DTC, App. Light 5/Reg. 6/Super 5
Published
2021-04-27
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
HEBTampon, Menstrual, Unscented
HHDPad, Menstrual, Unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2
HHDPad, Menstrual, UnscentedObstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191431000Interlude Rolled Tampons in Plastic ApplicatorAlbaad Fem2019-10-07HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810042480503PackageGS13In Commercial Distribution
20810042481897PackageGS13In Commercial Distribution
20810042482344PackageGS13In Commercial Distribution
20850373007250PackageGS11In Commercial Distribution
20850373007991PackageGS11In Commercial Distribution
30810042480521PackageGS13In Commercial Distribution
30850373007325PackageGS11In Commercial Distribution
30850373007936PackageGS11In Commercial Distribution
40810042481556PackageGS13In Commercial Distribution
40850373007087PackageGS11In Commercial Distribution
40850373007100PackageGS11In Commercial Distribution
00810042480094PrimaryGS10
00810042480339PrimaryGS10
00810042480346PrimaryGS10
00810042480391PrimaryGS10
00810042480407PrimaryGS10
00810042480506PrimaryGS10
00810042480520PrimaryGS10
00810042480568PrimaryGS10
00810042480629PrimaryGS10
00810042480636PrimaryGS10
00810042480643PrimaryGS10
00810042481084PrimaryGS10
00810042481312PrimaryGS10
00810042481558PrimaryGS10
00810042481893PrimaryGS10
00810042481909PrimaryGS10
00810042481916PrimaryGS10
00810042481978PrimaryGS10
00810042482036PrimaryGS10
00810042482272PrimaryGS10
00810042482289PrimaryGS10
00810042482340PrimaryGS10
00810042482432PrimaryGS10
00810042482449PrimaryGS10
00810042482463PrimaryGS10
00810042482494PrimaryGS10
00810042482500PrimaryGS10
00810042482517PrimaryGS10
00810042482531PrimaryGS10
00850003218335PrimaryGS10
00850003218496PrimaryGS10
00850003218892PrimaryGS10
00850003218908PrimaryGS10
00850003218915PrimaryGS10
00850003218939PrimaryGS10
00850373007089PrimaryGS10
00850373007096PrimaryGS10
00850373007102PrimaryGS10
00850373007119PrimaryGS10
00850373007126PrimaryGS10
00850373007133PrimaryGS10
00850373007256PrimaryGS10
00850373007294PrimaryGS10
00850373007300PrimaryGS10
00850373007317PrimaryGS10
00850373007324PrimaryGS10
00850373007935PrimaryGS10
00850373007997PrimaryGS10
10810042480572PrimaryGS10
00850373007041Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004248050310810042480503
2081004248189720810042481897
2081004248234420810042482344
2085037300725020850373007250
2085037300799120850373007991
3081004248052130810042480521
3085037300732530850373007325
3085037300793630850373007936
4081004248155640810042481556
4085037300708740850373007087
4085037300710040850373007100
00810042480094008100424800948100424800940810042480094
00810042480339008100424803398100424803390810042480339
00810042480346008100424803468100424803460810042480346
00810042480391008100424803918100424803910810042480391
00810042480407008100424804078100424804070810042480407
00810042480506008100424805068100424805060810042480506
00810042480520008100424805208100424805200810042480520
00810042480568008100424805688100424805680810042480568
00810042480629008100424806298100424806290810042480629
00810042480636008100424806368100424806360810042480636
00810042480643008100424806438100424806430810042480643
00810042481084008100424810848100424810840810042481084
00810042481312008100424813128100424813120810042481312
00810042481558008100424815588100424815580810042481558
00810042481893008100424818938100424818930810042481893
00810042481909008100424819098100424819090810042481909
00810042481916008100424819168100424819160810042481916
00810042481978008100424819788100424819780810042481978
00810042482036008100424820368100424820360810042482036
00810042482272008100424822728100424822720810042482272
00810042482289008100424822898100424822890810042482289
00810042482340008100424823408100424823400810042482340
00810042482432008100424824328100424824320810042482432
00810042482449008100424824498100424824490810042482449
00810042482463008100424824638100424824630810042482463
00810042482494008100424824948100424824940810042482494
00810042482500008100424825008100424825000810042482500
00810042482517008100424825178100424825170810042482517
00810042482531008100424825318100424825310810042482531
00850003218335008500032183358500032183350850003218335
00850003218496008500032184968500032184960850003218496
00850003218892008500032188928500032188920850003218892
00850003218908008500032189088500032189080850003218908
00850003218915008500032189158500032189150850003218915
00850003218939008500032189398500032189390850003218939
00850373007089008503730070898503730070890850373007089
00850373007096008503730070968503730070960850373007096
00850373007102008503730071028503730071020850373007102
00850373007119008503730071198503730071190850373007119
00850373007126008503730071268503730071260850373007126
00850373007133008503730071338503730071330850373007133
00850373007256008503730072568503730072560850373007256
00850373007294008503730072948503730072940850373007294
00850373007300008503730073008503730073000850373007300
00850373007317008503730073178503730073170850373007317
00850373007324008503730073248503730073240850373007324
00850373007935008503730079358503730079350850373007935
00850373007997008503730079978503730079970850373007997
1081004248057210810042480572
00850373007041008503730070418503730070410850373007041

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080294990
Device count
16
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00810042482944Cora02Tampons-4462026-10-29
00810042480360Cora02Tampons-426B0GPRY5KVW2026-04-08
10810042480572Cora06Pads-099X002NI163X2026-02-16
00810042482357Cora06Pads-0252026-02-16
00810042482364Cora06Pads-1302026-02-16
00810042482432Cora06Pads-1182026-02-16
00810042482449Cora06Pads-1192026-02-16
00810042482463Cora06Pads-1352026-02-16
00810042482494Cora06Pads-0422026-02-16
20810042482351Cora06Pads-0252026-02-16
20810042482368Cora06Pads-1302026-02-16
00810042480506Cora06Pads-0932021-05-19
00810042482531Cora02Tampons-3272026-01-31
00810042482401Cora02Tampons-1082026-01-21
00810042482395Cora02Tampons-1072026-01-21
00810042482418Cora02Tampons-1092026-01-21
00810042482425Cora02Tampons-1102026-01-21
00810042482500Cora02Tampons-423X001G01UHL2026-01-21
00810042482517Cora02Tampons-424X001UTA7YZ2026-01-21
30810042482396Cora02Tampons-1072026-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086435407With The FlowWith The Flow LLCHEB2026-11-04
00810042482944CoraCoraHEB2026-10-29
06972465050002Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-10
06972465050309Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-10
06972465050323Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-09
06972465050361Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-09
05060994741759DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741766DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741773DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741780DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
08806011638117Dong-A Pharmaceutical Co., Ltd.Dong-A Pharmaceutical Co., Ltd.HEB2026-09-29
05060994740752DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
05060994740769DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
00036000602579KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602586KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602593KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602609KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602616KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602647KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602654KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602661KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000606126KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00080196311661MEDLINEMEDLINE INDUSTRIES, INC.HHD2026-07-23
00810124537647VaklyAvaline Medical NJ Limited Liability CompanyHHD2026-07-10
00073010720091TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010720831TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721173TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721210This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721227TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721272TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25