Identity
- Trade Name
- Prime Plus FDA UDI
- Generic Name
- Surgical/medical face mask, single-use FDA UDI
- Device Name
- Earloop Procedure Mask, 7" x 3 5/8", Blue, 50/bx; 6 bxs/cs FDA UDI
- Model / Reference
- 21-2415 FDA UDI
- Description
- Earloop Procedure Mask, 7" x 3 5/8", Blue, 50/bx; 6 bxs/cs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818566016638 FDA UDI
- 510(k) Number
- K123787 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
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
Yes
FDA UDI
Category: Surgical/medical face mask, single-use
Prime Plus by Svs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical face mask, single-use.
- ProGear — Prestige Ameritech · Class II
- Precept® — Precept Medical Products, Inc. · Class II
- hcs — DYAD MEDICAL SOURCING, LLC · Class I
- Precept® — Precept Medical Products, Inc. · Class II
- AOSHANG — Tianjin Aoshang Outdoor Equipment Co., Ltd. · Class II
- 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
Cleared under the same submission
K123787 also covers:
- AIME 1776 — AIME USA LLC
- AIME 1776 — AIME USA LLC
- Azer Scientific — AZER SCIENTIFIC INCORPORATED
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- GREEN CROSS — Hubei Haixin Protective Products Group Co., Ltd
- PremierPro — SVS LLC
- PremierPro — SVS LLC
- PremierPro — SVS LLC
- PremierPro — SVS LLC
- PremierPro — SVS LLC
- PremierPro — SVS LLC
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
- Svs Llc
Sources (1)
- FDA UDI 1770b372-6e22-4f0c-ae1e-fd7e080ef7c2 35 fields · synced Jun 8, 2026