FDA.reportPublic FDA data

EZ Access™

Primary DI
B5911425XS0
Brand
EZ Access™
Company
V L V ASSOCIATES (INC)
Model
1425-XS
Device description
Wound Protector/ Retractor
Published
2017-12-18
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
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
B5911425XS3PackageHIBCC5In Commercial Distribution
B5911425XS0PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
118877356
Device count
1
DM exempt
true
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
00850005780168GU TekUCA5-95UCA5-952020-07-15
B5911425L0EZ Access™1425-L2017-12-18
B5911425M0EZ Access™1425-M2017-12-18
B5911425S0EZ Access™1425-S2017-12-18
B5911425XL0EZ Access™1425-XL2017-12-18
B5911425L3EZ Access™1425-L2017-12-18
B5911425M3EZ Access™1425-M2017-12-18
B5911425S3EZ Access™1425-S2017-12-18
B5911425XL3EZ Access™1425-XL2017-12-18
B5911425XS3EZ Access™1425-XS2017-12-18

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
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
00607915117221Alexis 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