FDA.reportPublic FDA data

Alexis® Lighted Wound Protector-Retractor

Primary DI
00607915148553
Brand
Alexis® Lighted Wound Protector-Retractor
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
CL302
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.
Published
2026-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTFIlluminator, Non-Remote
KGWRing (Wound Protector), Drape Retention, Internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTFIlluminator, Non-RemoteGeneral, Plastic Surgery2
KGWRing (Wound Protector), Drape Retention, InternalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607915148553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607915148553006079151485536079151485530607915148553

GMDN Terms#

Term, Definition table
TermDefinition
Radial surgical retractorA 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.

Regulatory Flags#

DUNS number
187129135
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607915110123Epix Laparoscopic ScissorsCB0302016-09-24
00607915110130Epix Laparoscopic ScissorsCB0402016-09-24
00607915142087Alexis® Lighted Wound Protector-RetractorCL4022026-04-22
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceC2R122026-04-22
00607915146498Suction Irrigation SystemC60012024-02-01
00607915146504Suction Irrigation SystemC60032024-02-01
00607915110147Epix Laparoscopic GrasperC41302016-08-30
00607915110154Epix Laparoscopic GrasperC41402016-08-30
00607915116866Direct Drive Reposable GraspersC41202016-08-30
00607915116873Direct Drive Reposable GraspersC41212016-08-30
00607915126773Inzii Retrieval SystemCD0042016-09-24
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915126964Epix ® Laparoscopic Dissector CY0102016-09-24
00607915117382Inzii Retrieval SystemCD0012016-09-24
00607915123406Inzii Retrieval SystemCD0032016-09-24
00607915128760Epix® Reusable ProbeC72022016-08-19
00607915128777Epix® Reusable ProbeC72112016-08-19
00607915128784Epix® Reusable ProbeC72042016-08-19
00607915128791Epix® Reusable ProbeC72052016-08-19
00607915146467Voyant Electrosurgical GeneratorEA0302026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607915142087Alexis® Lighted Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2026-04-22
00607915142087Alexis® Lighted Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONFTF2026-04-22
00607915140694Alexis ® Orthopaedic ProtectorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2024-07-11
00607915140700Alexis® Orthopaedic ProtectorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2024-07-11
00607915140328Alexis O Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2022-05-27
10607915140325Alexis® O Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2022-05-27
00607915138943Alexis® Orthopaedic ProtectorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2018-08-13
00607915138950Alexis® Orthopaedic ProtectorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2018-08-13
00607915138967Alexis® Orthopaedic ProtectorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2018-08-13
10607915138940Alexis® Orthopaedic ProtectorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2018-08-13
10607915138957Alexis® Orthopaedic ProtectorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2018-08-13
10607915138964Alexis® Orthopaedic ProtectorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2018-08-13
20607915139142MIGS Kit 1APPLIED MEDICAL RESOURCES CORPORATIONKGW2018-05-09
B5911425L0EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
B5911425M0EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
B5911425S0EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
B5911425XL0EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
B5911425XS0EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
B5911425L3EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
B5911425M3EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
B5911425S3EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
B5911425XL3EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
B5911425XS3EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
10607151002258BovieASPEN SURGICAL PRODUCTS, INC.FTF2017-02-10
00885380024798CARDINAL HEALTHCardinal Health 200, LLCFTF2016-12-29
20885380024792CARDINAL HEALTHCardinal Health 200, LLCFTF2016-12-29
00607151069056BovieASPEN SURGICAL PRODUCTS, INC.FTF2016-10-17
00607151069100BovieASPEN SURGICAL PRODUCTS, INC.FTF2016-10-17
00607151069155BovieASPEN SURGICAL PRODUCTS, INC.FTF2016-10-17
10607151069053BovieBOVIE MEDICAL CORPORATIONFTF2016-10-17