Identity
- Trade Name
- Lumindex 3 LED Transilluminator Barrier Sleeves FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, non-sterile FDA UDI
- Device Name
- cover light tip and Lumindex 3 handpiece to prevent cross-contamination. FDA UDI
- Model / Reference
- 7118837 FDA UDI
- Description
- cover light tip and Lumindex 3 handpiece to prevent cross-contamination. FDA UDI
Identifiers
- Catalog Number
- 71-18837 FDA UDI
- Primary DI / UDI-DI
- 00723896011164 FDA UDI
- FDA Product Code
- EIF FDA UDI
- GMDN Term
- Instrument/equipment drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument/equipment drape, single-use, non-sterile
Lumindex 3 LED Transilluminator Barrier Sleeves by Practicon, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Practicon, Inc.
Sources (1)
- FDA UDI 1eb30472-50c3-452c-9b79-db209d981bb6 34 fields · synced Jun 8, 2026