Identity
- Trade Name
- SCLERAL DEPRESSOR FDA UDI
- Generic Name
- Orbital depressor, reusable FDA UDI
- Device Name
- SCLERAL DEPRESSOR WITH CLIP DOUBLE ENDED TIP FDA UDI
- Model / Reference
- 10-3825 FDA UDI
- Description
- SCLERAL DEPRESSOR WITH CLIP DOUBLE ENDED TIP FDA UDI
Identifiers
- Catalog Number
- 10-3825 FDA UDI
- Primary DI / UDI-DI
- 00192896012196 FDA UDI
- FDA Product Code
- HNX FDA UDI
- GMDN Term
- Orbital depressor, 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orbital depressor, reusable
Scleral Depressor by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orbital depressor, reusable.
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- Ambler Surgical — Ambler Surgical, LLC · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, 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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 21bde72e-d44b-4391-8fcc-9ec7a1b5a32d 35 fields · synced Jun 6, 2026