Identity
- Trade Name
- EYE SPECULA FDA UDI
- Generic Name
- Eyelid speculum, single-use FDA UDI
- Device Name
- EYE SPECULA SOLID 15MM 1-1/2 INCH LENTH FDA UDI
- Model / Reference
- EYE SPECULA FDA UDI
- Description
- EYE SPECULA SOLID 15MM 1-1/2 INCH LENTH FDA UDI
Identifiers
- Catalog Number
- ESS FDA UDI
- Primary DI / UDI-DI
- B974ESS0 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Eyelid speculum, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 1.5 Inch FDA UDI
Category: Eyelid speculum, single-use
Eye Specula by Dr.frigz International(pvt)ltd, — 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
- Dr.frigz International(pvt)ltd,
Sources (1)
- FDA UDI f1e8ed38-628f-4fc1-9e37-a039f11cd568 35 fields · synced Jun 8, 2026