FDA.report

Pixie Cup

Primary DI
00850068130863
Brand
Pixie Cup
Company
Pixie Cup LLC
Model
B0GMXXDH8J
Device description
TAMPON REGULAR 12CT
Published
2026-03-19
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

Related Records

Contact Domains

Product Codes

CodeName
HEBTampon, Menstrual, Unscented

Product Code Classifications

CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K251033000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251033000Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.2025-08-13HEB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850068130863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068130863008500681308638500681308630850068130863

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

Contacts

PhoneEmail
4172430677info@pixiecup.com

Regulatory Flags

DUNS number
028513002
Device count
1
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
true
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 DIBrandModelCatalogPublished
00850068130870Pixie CupB0GMT9C1KH2026-03-19
00850068130887Pixie CupB0GMVH5VXD2026-03-19
00850068130894Pixie CupB0GMTK2PST2026-03-19
00850068130900Pixie CupB0GMTQHF3Z2026-03-19
00850068130917Pixie CupB0GMSQ371C2026-03-19
00850068130924Pixie CupB0GMTGNF1M2026-03-19
00850068130931Pixie CupB0GMT62Y3Y2026-03-19
00850068130948Pixie CupB0GMSKKK1S2026-03-19
00850016867407Pixie CupB0BFNLQC4L2026-01-09
00850068130221Pixie CupB0FJBG2VVN2025-08-02
00860417001393Pixie CupM2506PD2020A2025-06-26
00869352000348Pixie Cup250708G0032025-06-26
00715875074840Pixie CupM2506PC1915A2025-06-25
00850016867742Pixie CupM2506PC1911A2025-06-25
00850068130511Pixie CupEva Thermal (Pink)2025-05-26
00850068130528Pixie CupEva Thermal (Purple)2025-05-26
00850016867926Pixie CupB0DBVXH8NL 2024-11-12
00850016867117Pixie CupB09DPKS5172023-11-25
00850016867377Pixie CupB0BCZMPVF92023-11-20
00850016867728Pixie CupB0CGQ3YW9M2023-11-20

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10834533001411DG HealthDOLGENCORP, LLCHEB2026-03-23
10834533001442DG HealthDOLGENCORP, LLCHEB2026-03-23
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
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