Identity
- Trade Name
- THE BULLET, Alcon, INFINITECH FDA UDI
- Generic Name
- Fibreoptic operating light system FDA UDI
- Device Name
- The Bullet Endo Illuminator, Wide Angle Tip, 20Ga, 1.8m FDA UDI
- Model / Reference
- 8065010920 FDA UDI
- Description
- The Bullet Endo Illuminator, Wide Angle Tip, 20Ga, 1.8m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380650109200 FDA UDI
- FDA Product Code
- MPA FDA UDI
- GMDN Term
- Fibreoptic operating light system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 1.8 Meter FDA UDI
THE BULLET, Alcon, INFINITECH by Alcon Laboratories, Inc. — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI 49cc1216-4a22-496c-80e3-d19081b2417e 36 fields · synced May 31, 2026