Identity
- Trade Name
- INTCO FDA UDI
- Generic Name
- Menstrual tampon, unscented FDA UDI
- Device Name
- Menstrual Unscented Tampon FDA UDI
- Model / Reference
- TPVPEB-S2 FDA UDI
- Description
- Menstrual Unscented Tampon FDA UDI
Identifiers
- Primary DI / UDI-DI
- B845TPVPEBS21 FDA UDI
- 510(k) Number
- K192557 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Menstrual tampon, unscented
Intco by Intco Medical Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Menstrual tampon, unscented.
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- Shopko Tampons — Shopko · Class II
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- Family Wellness — Family Dollar Stores · Class II
- Tampax — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
Cleared under the same submission
K192557 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intco Medical Industries, Inc.
Sources (1)
- FDA UDI b7a74924-7ce6-44a5-8893-ccb984a1737c 34 fields · synced May 30, 2026