FDA.reportPublic FDA data

Alexis Wound Protector-Retractor

Primary DI
00607915117221
Brand
Alexis Wound Protector-Retractor
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
C8303
Device description
Wound Retractor and Protector
Published
2016-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGWRing (Wound Protector), Drape Retention, Internal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607915117228PackageGS15In Commercial Distribution
00607915117221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060791511722810607915117228
00607915117221006079151172216079151172210607915117221

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags#

DUNS number
187129135
Device count
1
Premarket exempt
true
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
00607915148553Alexis® Lighted Wound Protector-RetractorCL3022026-04-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607915142087Alexis® Lighted Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2026-04-22
00607915148553Alexis® Lighted Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2026-04-22
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
00607915117207Alexis Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2016-09-24
00607915117214Alexis Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2016-09-24
00607915117238Alexis Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2016-09-24
00607915117245Alexis Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2016-09-24
00607915117252Alexis O Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2016-09-24
00607915117269Alexis O Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2016-09-24
00607915117276Alexis O Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONKGW2016-09-24