FDA.reportPublic FDA data

EZ Access™

Primary DI
B5911425M3
Brand
EZ Access™
Company
V L V ASSOCIATES (INC)
Model
1425-M
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
OTC
false
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
B5911425M3PackageHIBCC5In Commercial Distribution
B5911425M0PrimaryHIBCC0

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118877356
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
B5911425XS0EZ Access™1425-XS2017-12-18
B5911425L3EZ Access™1425-L2017-12-18
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
B5911425XS0EZ Access™V L V ASSOCIATES (INC)KGW2017-12-18
B5911425L3EZ 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