Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- General-purpose light source FDA UDI
- Device Name
- KleenSpec Illumination System (with cord)—4.7 V Halogen Light Handle with on/off switch and transformer, 110-130 V, 60 Hz for North America FDA UDI
- Model / Reference
- 901070 FDA UDI
- Description
- KleenSpec Illumination System (with cord)—4.7 V Halogen Light Handle with on/off switch and transformer, 110-130 V, 60 Hz for North America FDA UDI
Identifiers
- Catalog Number
- 78900 FDA UDI
- Primary DI / UDI-DI
- 00732094236460 FDA UDI
- 510(k) Number
- K120743 FDA UDI
- FDA Product Code
- HIB FDA UDI
- GMDN Term
- General-purpose light source FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose light source
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Welch Allyn, Inc.
Sources (1)
- FDA UDI 6998b363-d953-4100-9b92-bdad141edf78 36 fields · synced Jun 8, 2026