Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Corneal trephine, single-use FDA UDI
- Device Name
- Non-vacuum trephine punch, 8.00mm diameter, for donor cornea, sterile, disposable, box of 1 FDA UDI
- Model / Reference
- Non-vacuum trephine punch FDA UDI
- Description
- Non-vacuum trephine punch, 8.00mm diameter, for donor cornea, sterile, disposable, box of 1 FDA UDI
Identifiers
- Catalog Number
- 340800 FDA UDI
- Primary DI / UDI-DI
- 00190660200466 FDA UDI
- FDA Product Code
- HRH FDA UDI
- GMDN Term
- Corneal trephine, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Corneal trephine, single-use
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Corneal trephine, single-use.
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- SURGISTAR — Surgistar Inc. · Class I
- Coronet — Network Medical Products, Ltd. · Class I
- coronet — Network Medical Products, Ltd. · Class I
- coronet — Network Medical Products, Ltd. · Class I
- Coronet — Network Medical Products, Ltd. · Class I
- SURGISTAR — Surgistar 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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 43f32ca6-9719-4861-9678-eafe1ac2881e 35 fields · synced Jun 8, 2026