Identity
- Trade Name
- SURGISTAR FDA UDI
- Generic Name
- Corneal trephine, single-use FDA UDI
- Model / Reference
- 310875 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00878799004765 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
No
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
No
FDA UDI
Category: Corneal trephine, single-use
Surgistar by Surgistar Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- coronet — Network Medical Products, Ltd. · Class I
- coronet — Network Medical Products, Ltd. · Class I
- Coronet — Network Medical Products, Ltd. · Class I
- Ambler Surgical — Ambler Surgical, LLC · 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 |
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Manufacturer
- Manufacturer
- Surgistar Inc.
Sources (1)
- FDA UDI 3d384f17-3e7b-484a-8598-7e9b7bf2b3b6 33 fields · synced Jun 1, 2026