← Back to catalogue
Disposable valve for trocar D=3, 5mm
FDA UDIClass II (US FDA UDI)
by Medica Corp.
Identity
- Trade Name
- Disposable valve for trocar D=3,5mm FDA UDI
- Generic Name
- Laparoscopic access cannula seal, single-use FDA UDI
- Model / Reference
- C35-SEAL-1 FDA UDI
Identifiers
- Catalog Number
- C35-SEAL-1 FDA UDI
- Primary DI / UDI-DI
- E496C35SEAL11 FDA UDI
- 510(k) Number
- K140101 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Laparoscopic access cannula seal, 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 seal, single-use
Disposable valve for trocar D=3, 5mm by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic access cannula seal, single-use.
- Convertible Trocar System — APPLIED MEDICAL RESOURCES CORP. · Class II
- Gimmi — Gimmi GmbH · Class II
- Gimmi — Gimmi GmbH · Class II
- Gimmi — Gimmi GmbH · Class II
- Gimmi — Gimmi GmbH · Class II
- Gimmi — Gimmi GmbH · Class II
- Gimmi — Gimmi GmbH · Class II
- GloShield — JACKSON MEDICAL LLC · Class I
Cleared under the same submission
K140101 also covers:
- "Allis" insert L=50cm D=5mm — Medica Corp.
- 20mm Tapered insert L=35cm D=5mm — Medica Corp.
- 30mm Fenestrated insert L=35cm D=5mm — Medica Corp.
- C35-"C" Shape Dissector, Jaw Insert L=33mm D=3, 5mm — Medica Corp.
- C35-20mm Fenestrated insert L=330mm D=3, 5mm — Medica Corp.
- C35-330mm insert with 2 movable Fenestrated jaws length 20mm D=3, 5mm — Medica Corp.
- C35-Allis Grasping Forceps, 2 mobile jaws Insert L=33mm D=3, 5mm — Medica Corp.
- C35-Bipolar Handle L 33cm D 3, 5mm — Medica Corp.
- C35-Classical HOOK L=330mm D=3, 5mm — Medica Corp.
- C35-Clutch 2 mobile jaws insert L 33cm D 3, 5mm — Medica Corp.
- C35-Clutch insert L=330mm D=3, 5mm — Medica Corp.
- C35-Hand Activated HOOK L=330mm — Medica Corp.
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
- Medica Corp.
Sources (1)
- FDA UDI 49811160-4665-4dbd-ad8f-fb9d08f4a7b0 34 fields · synced Jun 8, 2026