Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Scleral marker, reusable FDA UDI
- Device Name
- Lu-Mendez fixation ring/incision guide, 4 3/8'', for assistance with LRI incisions, 11.0mm i.d., blunt teeth, round handle FDA UDI
- Model / Reference
- Lu-Mendez fixation ring/incision guide FDA UDI
- Description
- Lu-Mendez fixation ring/incision guide, 4 3/8'', for assistance with LRI incisions, 11.0mm i.d., blunt teeth, round handle FDA UDI
Identifiers
- Catalog Number
- 3410E FDA UDI
- Primary DI / UDI-DI
- 00190660036980 FDA UDI
- FDA Product Code
- HNH FDA UDI
- GMDN Term
- Scleral marker, 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
Moist Heat or Steam Sterilization FDA UDI
Category: Scleral marker, reusable
Ambler Surgical by Ambler Surgical, LLC — 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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 116031b7-916e-4c29-80bb-1b4fba6a7ae9 35 fields · synced May 30, 2026