Identity
- Trade Name
- Toptolife FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- Procedure Masks, Ear loops, Blue; (ASTM Level 1) FDA UDI
- Model / Reference
- 141304101 FDA UDI
- Description
- Procedure Masks, Ear loops, Blue; (ASTM Level 1) FDA UDI
Identifiers
- Catalog Number
- 141304101 FDA UDI
- Primary DI / UDI-DI
- 10850036987281 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/medical face mask, non-antimicrobial, single-use
Toptolife by Toptolife, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical face mask, non-antimicrobial, single-use.
- Medicom AssureMask — AMD Medicom Inc · Class II
- BENCO — BENCO DENTAL SUPPLY CO. · Class II
- Medicom AssureMask — AMD Medicom Inc · Class II
- Criterion — HENRY SCHEIN, INC. · Class II
- PRIMED — priMED Medical Products Inc · Class II
- NOVAPLUS — O&M HALYARD, INC. · Class II
- MEDICOM SAFEMASK CLASSICS — AMD Medicom Inc · Class II
- THE SEA — Mexpo International, Inc. · Class II
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
- Toptolife, LLC
Sources (1)
- FDA UDI e3fbffd7-da85-4124-806f-9484292f50ae 34 fields · synced Jun 1, 2026