Identity
- Trade Name
- Ophthlamic Speculum FDA UDI
- Generic Name
- Eyelid speculum, single-use FDA UDI
- Device Name
- INFANT SPECULUM 4MM SOLID (10/BX) FDA UDI
- Model / Reference
- K20-1017 FDA UDI
- Description
- INFANT SPECULUM 4MM SOLID (10/BX) FDA UDI
Identifiers
- Catalog Number
- K20-1017 FDA UDI
- Primary DI / UDI-DI
- 00841668115541 FDA UDI
- FDA Product Code
- HNC FDA UDI
- GMDN Term
- Eyelid speculum, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Eyelid speculum, single-use
Ophthlamic Speculum by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Eyelid speculum, single-use.
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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
- Katena Products, Inc.
Sources (1)
- FDA UDI 75dbee63-2548-4e80-83cd-7f34633cc1a8 35 fields · synced Jun 12, 2026