Identity
- Trade Name
- FLEXIBLE TROCAR 8mm FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- MAJ-1058 8MM FLEX TROCAR FOR LTF-160 FDA UDI
- Model / Reference
- MAJ-1058 FDA UDI
- Description
- MAJ-1058 8MM FLEX TROCAR FOR LTF-160 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170140594 FDA UDI
- 510(k) Number
- K013617 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
- 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: Laparoscopic access cannula, single-use
FLEXIBLE TROCAR 8mm by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Laparoscopic access cannula, single-use.
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Cleared under the same submission
K013617 also covers:
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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI b722aa41-b383-481d-a750-236454a9cae7 35 fields · synced Jun 8, 2026