FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TROGARD
DI: 30653405011990
·
Model: 60-6050-081
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
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Basic Information
- Brand Name
- TROGARD
- Primary DI
- 30653405011990
- Version / Model
- 60-6050-081
- Catalog Number
- 60-6050-081
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2022-06-08
- Public Version Status
- Update
- Public Device Record Key
- 0023fb6c-7c39-4d0e-96a1-24bd20546d2a
- Distribution End Date
- 2022-06-07
Device Description
TROGARD BLUNT TIP TROCAR SYSTEM, 10/11MM X 120MM
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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Package | 20653405011993 | GS1 | BOX | 6 | Not in Commercial Distribution | 2022-06-07 |
| Primary | 30653405011990 | GS1 | ||||
| Unit of Use | 00653405011999 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K001597 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Blunt Tip Trocar |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 32 Degrees Celsius