Identity
- Trade Name
- Aspen® Flexible Light Handle Cover FDA UDI
- Generic Name
- Light source adaptor FDA UDI
- Device Name
- Provides a sterile interface between the operating room surgical lamps (non-sterile) and the Surgeon or Nurse (sterile). FDA UDI
- Model / Reference
- FLEX02NS FDA UDI
- Description
- Provides a sterile interface between the operating room surgical lamps (non-sterile) and the Surgeon or Nurse (sterile). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840113209293 FDA UDI
- 510(k) Number
- K020304 FDA UDI
- FDA Product Code
- FAT FDA UDI
- GMDN Term
- Light source adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5365 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Light source adaptor
Aspen® Flexible Light Handle Cover by Aspen Surgical Products, 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
- Aspen Surgical Products, Inc.
Sources (1)
- FDA UDI f71852d5-384a-4f09-a9c5-7e21c83acef0 35 fields · synced Jun 9, 2026