Identity
- Trade Name
- Light Shield™ FDA UDI
- Generic Name
- Medical equipment handle cover, single-use FDA UDI
- Model / Reference
- NB8001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20809160022068 FDA UDI
- 510(k) Number
- K020304 FDA UDI
- FDA Product Code
- FTA FDA UDI
- GMDN Term
- Medical equipment handle cover, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
Yes
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
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Medical equipment handle cover, single-use
Light Shield™ by Medical Action Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020304 also covers:
- AVID TruCustom — AVID MEDICAL, INC.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc.
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, 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 |
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Manufacturer
- Manufacturer
- Medical Action Industries Inc.
Sources (1)
- FDA UDI a2ecdec7-52f2-4c82-8b69-49fe67a10d31 33 fields · synced May 30, 2026