Identity
- Trade Name
- ADDaSEAL RE Adhesive Face Mask Strips FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- Adhesive strip to be placed on the bridge of any face mask to create an airtight seal. Adhesive is repositionable on the skin side, making it better for sensitive skin and longer procedures. FDA UDI
- Model / Reference
- 7154411 FDA UDI
- Description
- Adhesive strip to be placed on the bridge of any face mask to create an airtight seal. Adhesive is repositionable on the skin side, making it better for sensitive skin and longer procedures. FDA UDI
Identifiers
- Catalog Number
- 7154411 FDA UDI
- Primary DI / UDI-DI
- 00723896018897 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class I 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/medical face mask, non-antimicrobial, single-use
ADDaSEAL RE Adhesive Face Mask Strips by Practicon, Inc. — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Practicon, Inc.
Sources (1)
- FDA UDI 8c99d915-0a32-4dad-8a8d-784215ce2701 34 fields · synced May 30, 2026