Identity
- Trade Name
- Snowden-Pencer FDA UDI
- Generic Name
- General-purpose light source FDA UDI
- Device Name
- Snowden-Pencer MIS SNOWDEN-PENCER HEADLIGHT SYSTEM, ADJUSTABLE HEADBAND WITH 3.5MM X 9FT BIFURCATED FIBER OPTIC CABLE FDA UDI
- Model / Reference
- 89-8461 FDA UDI
- Description
- Snowden-Pencer MIS SNOWDEN-PENCER HEADLIGHT SYSTEM, ADJUSTABLE HEADBAND WITH 3.5MM X 9FT BIFURCATED FIBER OPTIC CABLE FDA UDI
Identifiers
- Catalog Number
- 89-8461 FDA UDI
- Primary DI / UDI-DI
- 10885403067884 FDA UDI
- 510(k) Number
- K893458 FDA UDI
- FDA Product Code
- EBA FDA UDI
- GMDN Term
- General-purpose light source FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4630 FDA UDI
- Commercial Distribution
- Not 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
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
Moist Heat or Steam Sterilization FDA UDI
Snowden-Pencer by Carefusion 2200, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Carefusion 2200, Inc.
Sources (1)
- FDA UDI 930e0807-c89e-4577-aee3-b678e40271a5 37 fields · synced Sep 18, 2026