FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDOPATH XCEL
DI: 10705036002284
·
Model: K12LT
·
ETHICON ENDO-SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ENDOPATH XCEL
- Primary DI
- 10705036002284
- Version / Model
- K12LT
- Catalog Number
- K12LT
- Company Name
- ETHICON ENDO-SURGERY, LLC
- Labeler DUNS
- 044606982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-15
- Public Version
- 6
- Public Version Date
- 2022-12-26
- Public Version Status
- Update
- Public Device Record Key
- 887ca9df-b1ae-4869-831c-a071e86fa66e
Device Description
Endopath XCEL Dilating Tip Trocar Paks containing: 1 Dilating Tip trocar with Stability Sleeve and 1 Stability Sleeve for Dilating Tip Trocar
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 |
|---|---|---|---|---|---|---|
| Package | 30705036002288 | GS1 | CASE | 24 | In Commercial Distribution | |
| Primary | 10705036002284 | GS1 | ||||
| Package | 20705036002281 | GS1 | BOX | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]