Identity
- Trade Name
- Neonatal Ocular Exam Kit 2-pack FDA UDI
- Generic Name
- Eyelid speculum, single-use FDA UDI
- Device Name
- Neonatal Speculum & Depressor 2-pack FDA UDI
- Model / Reference
- 10812594012485 FDA UDI
- Description
- Neonatal Speculum & Depressor 2-pack FDA UDI
Identifiers
- Catalog Number
- N6502 FDA UDI
- Primary DI / UDI-DI
- 10812594012485 FDA UDI
- FDA Product Code
- FXG FDA UDI
- GMDN Term
- Eyelid speculum, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.1800 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
High-level Disinfectant FDA UDI
Category: Eyelid speculum, single-use
Neonatal Ocular Exam Kit 2-pack by Neotech Products LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eyelid speculum, single-use.
- EYE SPECULA — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- Malosa Medical — Beaver-Visitec International, Inc. · Class I
- Sklar — Sklar Corporation · Class I
- Barraquer Neonatal Speculum with Finger tips — BLINK MEDICAL LIMITED · Class I
- Sklar — Sklar Corporation · Class I
- EYE SPECULA — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- Speculum Neo-Natal Angled Temporal — BLINK MEDICAL LIMITED · Class I
- MSI Precision Specialty Instruments — Med Saver, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neotech Products LLC
Sources (1)
- FDA UDI 9e771302-2c33-47f8-89bf-7a41d6dd75dc 34 fields · synced May 31, 2026