Identity
- Trade Name
- PATTERSON FDA UDI
- Generic Name
- Surgical/medical face mask, single-use FDA UDI
- Device Name
- MASK EARLOOP SENS SKIN 50 WHT FDA UDI
- Model / Reference
- 071133214 FDA UDI
- Description
- MASK EARLOOP SENS SKIN 50 WHT FDA UDI
Identifiers
- Primary DI / UDI-DI
- D6620711332142 FDA UDI
- 510(k) Number
- K823078 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, 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
Yes
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: Surgical/medical face mask, single-use
Patterson by Patterson Dental Supply, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical/medical face mask, single-use.
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Cleared under the same submission
K823078 also covers:
- KIMBERLY-CLARK® Fluidshield* Fog-Free Surgical Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Fluidshield™ Fog-Free Procedure Mask with Visor — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Fluidshield™ Fog-Free Surgical Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Fluidshield™ Fog-Free Surgical Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Fluidshield™ Procedure Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Procedure Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Procedure Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Procedure Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Soft Touch™ II Surgical Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® The Lite One™ Surgical Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
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
- Patterson Dental Supply, Inc.
Sources (1)
- FDA UDI 751482dd-36d8-4dd0-b13b-4b32b6b8655b 34 fields · synced Jun 6, 2026