Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Surgical irrigation/aspiration system FDA UDI
- Device Name
- 5mm 33cm Adaptable Suction Sheath FDA UDI
- Model / Reference
- SD12719 FDA UDI
- Description
- 5mm 33cm Adaptable Suction Sheath FDA UDI
Identifiers
- Catalog Number
- SD12719 FDA UDI
- Primary DI / UDI-DI
- B382SD127190 FDA UDI
- FDA Product Code
- GCX FDA UDI
- GMDN Term
- Surgical irrigation/aspiration system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 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
Dimensions & Sizes
- Size
- Length — 33 Centimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDI
Category: Surgical irrigation/aspiration system
Surgical Direct by Surgical Direct, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LMI IRRIGATION (STRAIGHT) CATHETER — LUCAS MEDICAL 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 |
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Manufacturer
- Manufacturer
- Surgical Direct, Inc.
Sources (1)
- FDA UDI 1636a168-238d-40e5-9625-58204aa8117c 36 fields · synced Jun 8, 2026