Identity
- Trade Name
- Synergetics FDA UDI
- Generic Name
- Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- 25ga Stellaris Elite Vitrectomy Probe FDA UDI
- Model / Reference
- SE5625 FDA UDI
- Description
- 25ga Stellaris Elite Vitrectomy Probe FDA UDI
Identifiers
- Catalog Number
- SE5625 FDA UDI
- Primary DI / UDI-DI
- 10841305111438 FDA UDI
- FDA Product Code
- HQE FDA UDI
- GMDN Term
- Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4150 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)
Synergetics by Synergetics Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT).
- Synergetics — SYNERGETICS USA, INC. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synergetics Usa, Inc.
Sources (1)
- FDA UDI 78345961-f852-4425-9be1-492c2c4c7257 35 fields · synced Jun 1, 2026