FDA UDI
In Commercial Distribution
🇺🇸 United States
20118ADL 33cm Laparoscopic J-Wire Split; Blue PTFE; Black Insulation; PL
DI: 00787551013412
·
Model: 20118ADL
·
XODUS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- 20118ADL 33cm Laparoscopic J-Wire Split; Blue PTFE; Black Insulation; PL
- Primary DI
- 00787551013412
- Version / Model
- 20118ADL
- Catalog Number
- 20118ADL
- Company Name
- XODUS MEDICAL, INC.
- Labeler DUNS
- 868042664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 192ba7bb-e1ff-402d-b803-7a98b9ddae22
Device Description
20118ADL 33cm Laparoscopic J-Wire Split; Blue PTFE; Black Insulation; PL
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
- Yes
- 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
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, cutting & coagulation & accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61874 | Open-surgery electrosurgical electrode, monopolar, single-use | An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10787551013419 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 00787551013412 | GS1 | ||||
| Package | 20787551013416 | GS1 | CASE | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(724)337-5500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081647 | 000 |