FDA.report

Scarlet

Primary DI
00850074347002
Brand
Scarlet
Company
RedDrop, Inc.
Model
1
Device description
tampon
Published
2025-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HEBTampon, Menstrual, Unscented

Product Code Classifications

CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850074347002PrimaryGS10
00850074347026Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850074347002008500743470028500743470020850074347002
00850074347026008500743470268500743470260850074347026

GMDN Terms

TermDefinition
Menstrual tampon, unscentedA non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
117436052
Device count
18
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
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 Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10834533001411DG HealthDOLGENCORP, LLCHEB2026-03-23
10834533001442DG HealthDOLGENCORP, LLCHEB2026-03-23
00850068130863Pixie CupPixie Cup LLCHEB2026-03-19
00850068130870Pixie CupPixie Cup LLCHEB2026-03-19
00850068130887Pixie CupPixie Cup LLCHEB2026-03-19
00850068130894Pixie CupPixie Cup LLCHEB2026-03-19
00850068130900Pixie CupPixie Cup LLCHEB2026-03-19
00850068130917Pixie CupPixie Cup LLCHEB2026-03-19
00850068130924Pixie CupPixie Cup LLCHEB2026-03-19
00850068130931Pixie CupPixie Cup LLCHEB2026-03-19
00850068130948Pixie CupPixie Cup LLCHEB2026-03-19
00810152230848Public GoodsDon't Run Out, Inc.HEB2026-03-09
00036000597295U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
30810042482396CoraCoraHEB2026-01-21
20810042482405CoraCoraHEB2026-01-21
20810042482412CoraCoraHEB2026-01-21
20810042482429CoraCoraHEB2026-01-21
00628719704073Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704127Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704134Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704639Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628942539305Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628942539329Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628942539336Iris + ArloIris + Arlo Inc.HEB2026-01-06
00990498500215Iris + ArloIris + Arlo Inc.HEB2026-01-06
00990498500222Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704066Iris + ArloIris + Arlo Inc.HEB2026-01-05
00628942539299Iris + ArloIris + Arlo Inc.HEB2026-01-05
10050428273484CVS Health TamponsWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHEB2025-12-31
40073010720747TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2025-12-19