Identity
- Trade Name
- Oph. Spec. FDA UDI
- Generic Name
- Eyelid speculum, reusable FDA UDI
- Device Name
- Sauer Speculum, Infant, 10mm, Temporal FDA UDI
- Model / Reference
- 08-08130 FDA UDI
- Description
- Sauer Speculum, Infant, 10mm, Temporal FDA UDI
Identifiers
- Catalog Number
- 08-08130 FDA UDI
- Primary DI / UDI-DI
- 00841668119525 FDA UDI
- FDA Product Code
- HNC FDA UDI
- GMDN Term
- Eyelid speculum, reusable 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
No
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
Dimensions & Sizes
- Size
- Length — 10 Millimeter FDA UDI
Category: Eyelid speculum, reusable
Oph. Spec. by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eyelid speculum, reusable.
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- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- COOK EYE SPECULUM — SONTEC INSTRUMENTS, 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 |
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Manufacturer
- Manufacturer
- Katena Products, Inc.
Sources (1)
- FDA UDI 7ece9016-bfc6-40c1-a49a-9b06d2eec3d8 36 fields · synced Jun 12, 2026