DynaCare Organic Tampons, Regular, Cardboard Applicator

FDA UDI

Class II (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: DynaCare Organic Tampons, Regular, Cardboard Applicator FDA UDI
Generic Name: Menstrual tampon, unscented FDA UDI
Device Name: Regular: 6-9 G, Super 3-12 G, Super Plus: 12-15 G. Ingredients: 100% Organic Cotton (Wadding), 100% Organic Cotton (Non-Woven), Organic Cotton (Withdrawal Cord), Cardboard (Applicator). Warning: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information. FDA UDI
Model / Reference: 1378 FDA UDI
Description: Regular: 6-9 G, Super 3-12 G, Super Plus: 12-15 G. Ingredients: 100% Organic Cotton (Wadding), 100% Organic Cotton (Non-Woven), Organic Cotton (Withdrawal Cord), Cardboard (Applicator). Warning: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information. FDA UDI

Identifiers

Primary DI / UDI-DI: 00840117343405 FDA UDI
510(k) Number: K090819 FDA UDI
K241064 FDA UDI
FDA Product Code: HEB FDA UDI
GMDN Term: Menstrual tampon, unscented FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Menstrual tampon, unscented

DynaCare Organic Tampons, Regular, Cardboard Applicator by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K241064 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dynarex Corp.

Sources (1)

FDA UDI 5c2175f6-1ee5-4b52-9525-523e8ba44e4d 34 fields · synced May 30, 2026