Identity
- Trade Name
- Premium Disposable Trocar FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- Disposable Unshielded Trocar FDA UDI
- Model / Reference
- C0507 FDA UDI
- Description
- Disposable Unshielded Trocar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915114442 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 5 Millimeter FDA UDILength — 100 Millimeter FDA UDI
The Premium Disposable Trocar is a single-use, laparoscopic access cannula designed for percutaneous insertion into the abdominal wall. With its shut-off valve and dedicated sealing devices, this device provides a secure and leak-proof connection to facilitate instrument introduction and puncture of the abdominal wall.
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
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI 743624d1-2d0b-4fa0-a5f0-52498a474734 36 fields · synced Jul 6, 2026