FUJIFILM
Basic Information
- Brand Name
- FUJIFILM
- Primary DI
- 04547410447866
- Version / Model
- DLT05S
- Company Name
- FUJIFILM CORPORATION
- Labeler DUNS
- 713565195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-09
- Public Version
- 1
- Public Version Date
- 2020-12-17
- Public Version Status
- New
- Public Device Record Key
- c3f0deba-b0a6-4f05-90f7-efab00224fde
Device Description
The product is comprised of a minimally invasive surgical trocar (Outer sheath sleeve, Inner trocar and Optical obturator) and accessories (Lens cleaning syringe and Lens cleaning tube). There are two tubes with a luer lock connector attached to the InterLock Trocar. The tube connected to the Outer sheath sleeve is used for abdominal insuf ation and the other attached to the Inner trocar is used for the objective lens cleaning function. The design of the InterLock Trocar maintains the laparoscope and the hand instrument in direct alignment. This feature provides a surgeon with control of the laparoscope image and the hand instrument with one hand, meaning the laparoscope is in direct alignment or parallel to the hand instrument. The hand instrument is always in the eld of view of the laparoscope. The laparoscope does not need to be held by another surgeon or health care personnel. The InterLock Trocar holds the laparoscope and no additional surgeon or assistant is required to control operation of the laparosco
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42412 | Laparoscopic access cannula, single-use | A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04547410447866 | GS1 | ||||
| Previous | 00856853006009 | GS1 |
Customer Contacts
- Phone
- (800)272-8465
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170084 | 000 |