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20118ADL 33cm Laparoscopic J-Wire Split +3 more models
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 20118ADL 33cm Laparoscopic J-Wire Split; Blue PTFE; Black Insulation; PL FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- 20118ADL 33cm Laparoscopic J-Wire Split; Blue PTFE; Black Insulation; PL FDA UDI
- Model / Reference
- 20118ADL FDA UDI
- Description
- 20118ADL 33cm Laparoscopic J-Wire Split; Blue PTFE; Black Insulation; PL FDA UDI
Identifiers
- Catalog Number
- 20118ADL FDA UDI
- Primary DI / UDI-DI
- 00787551013412 FDA UDI
- 510(k) Number
- K081647 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Models / Variants
- Blue PTFE FDA UDIBlack Insulation FDA UDIPL FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
20118ADL 33cm Laparoscopic J-Wire Split +3 more models by Xodus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — 4 models
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- Symmetry Olsen — Olsen Medical · Class II
- FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
- star Bipolar RF Electrode — STARMED CO., LTD · Class IIb
- VIVA RF electrode — STARMED CO., LTD · Class IIb
- CONMED — Conmed Corporation · Class II
- HT-DT-NTW45 — Zhejiang Jinhua Huatong Medical Appliance Co., Ltd · Class IIb
- COLORADO — Stryker Leibinger · Class II
Cleared under the same submission
K081647 also covers:
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC.
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 |
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Manufacturer
- Manufacturer
- Xodus Medical, Inc.
Sources (1)
- FDA UDI 192ba7bb-e1ff-402d-b803-7a98b9ddae22 36 fields · synced Jun 8, 2026