Identity
- Trade Name
- Edge™ EarLoop Procedure Masks FDA UDI
- Generic Name
- Surgical/medical face mask, single-use FDA UDI
- Device Name
- Earloop Procedure Masks, ASTM Level 1, Blue, Box FDA UDI
- Model / Reference
- 5722006 FDA UDI
- Description
- Earloop Procedure Masks, ASTM Level 1, Blue, Box FDA UDI
Identifiers
- Catalog Number
- 5722006 FDA UDI
- Primary DI / UDI-DI
- 10818365020956 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
Edge™ EarLoop Procedure Masks by Edge Endo Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical face mask, single-use.
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- Precept® — Precept Medical Products, Inc. · Class II
- Precept® — Precept Medical Products, Inc. · Class II
- Surgical Face Mask — Foshan Nanhai Plus Medical Co., Ltd · 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 |
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Manufacturer
- Manufacturer
- Edge Endo Llc
Sources (1)
- FDA UDI 646b05d6-c8fe-416b-a01a-e5f07e94c38c 35 fields · synced Jun 1, 2026