Identity
- Trade Name
- Aspen® Rigid Light Handle Adapter FDA UDI
- Generic Name
- Light source adaptor FDA UDI
- Device Name
- Intent to be used with Aspen Surgical Disposable light Handle covers. FDA UDI
- Model / Reference
- LT-9702X FDA UDI
- Description
- Intent to be used with Aspen Surgical Disposable light Handle covers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840113223831 FDA UDI
- 510(k) Number
- K020304 FDA UDI
- FDA Product Code
- FTA FDA UDI
- GMDN Term
- Light source adaptor 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
No
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® Rigid Light Handle Adapter 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 0cac8912-0aa0-40e6-b697-01e23759c9a2 35 fields · synced Jun 9, 2026