Alexis® Lighted Wound Protector-Retractor
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Alexis® Lighted Wound Protector-Retractor
- Primary DI
- 00607915142087
- Version / Model
- CL402
- Company Name
- APPLIED MEDICAL RESOURCES CORPORATION
- Labeler DUNS
- 187129135
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-22
- Public Version
- 1
- Public Version Date
- 2026-04-30
- Public Version Status
- New
- Public Device Record Key
- aca4d322-b12f-4b40-8d56-ec71b1c66fa9
Device Description
The Alexis Lighted Wound Protector-Retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to provide supplemental illumination and protect against wound contamination during both laparoscopic and open surgery. The Alexis Lighted Wound Protector-Retractor is capable of temporarily closing an incision to maintain pneumoperitoneum during laparoscopic surgery, or to serve as an additional trocar port site. In addition, the device may be used to access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures.
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
- Yes
- 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 |
|---|---|---|---|---|
| KGW | Ring (Wound Protector), Drape Retention, Internal | General, Plastic Surgery | 878.4370 | 2 |
| FTF | Illuminator, Non-Remote | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47431 | Radial surgical retractor | A sterile surgical device intended to be inserted across a surgical incision to separate the margins of the incision to create a conduit to the underlying organs/tissues during hand-assisted minimally-invasive and open surgery. It consists of an external and internal fixed or retracting ring interconnected with an elastomeric sleeve/sheath intended to also provide protection against wound contamination, and may include channels/tubing to allow wound-edge irrigation. Also known as a lap disc, hand access device, handport, or protector, it may be used with or without a seal cap for colorectal, urological, gynaecological, or general abdominal surgical procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607915142084 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00607915142087 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K253531 | 000 |