Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Scleral marker, reusable FDA UDI
- Device Name
- Ambler Toric Intra-op axis marker II, 4 7/8'', two 2.0mm marking blades, cutouts on the two 90 degrees positions for easy alignment, round handle, titanium FDA UDI
- Model / Reference
- Ambler Toric Intra-op axis marker II FDA UDI
- Description
- Ambler Toric Intra-op axis marker II, 4 7/8'', two 2.0mm marking blades, cutouts on the two 90 degrees positions for easy alignment, round handle, titanium FDA UDI
Identifiers
- Catalog Number
- 8311T FDA UDI
- Primary DI / UDI-DI
- 00190660102975 FDA UDI
- FDA Product Code
- HMR FDA UDI
- GMDN Term
- Scleral marker, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4570 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
Similar devices
Also classified as Scleral marker, reusable.
- AESCULAP — AESCULAP, INC. · Class I
- AESCULAP — AESCULAP, INC. · Class I
- AESCULAP — AESCULAP, INC. · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Marker, Ocular — Katena Products, Inc. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Ambler Surgical — Ambler Surgical, LLC · 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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 4bbdbca6-c887-4412-9c32-80dfdd6c8f17 35 fields · synced May 30, 2026