Identity
- Trade Name
- XHL xenon spare bulb, 3.5 V FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- for beta 200 FDA UDI
- Model / Reference
- 10-145-99 FDA UDI
- Description
- for beta 200 FDA UDI
Identifiers
- Catalog Number
- 10-145-99 FDA UDI
- Primary DI / UDI-DI
- 04053755143931 FDA UDI
- FDA Product Code
- EQH FDA UDI
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4350 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Otoscope, direct
XHL xenon spare bulb, 3.5 V by Spiggle & Theis Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Otoscope, direct.
- TytoHome — TYTO CARE LTD · Class II
- TytoHome — TYTO CARE LTD · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
- Safety 1st — DOREL JUVENILE GROUP, INC. · Class I
- BETA 200 VET. OTOSCOPE — Heine Optotechnik GmbH & Co. KG · Class I
- Firefly — Firefly Global · Class I
- Otoscope — Shenzhen Teslong Technology Co., Ltd · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
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
- Spiggle & Theis Medizintechnik GmbH
Sources (1)
- FDA UDI bd39cee2-ed23-4687-9b3d-3d2e0b224498 35 fields · synced Jun 8, 2026