FDA.reportPublic FDA data

CONVERTORS

Primary DI
10885380064340
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
D37106310
Catalog number
D37106310
Device description
Vi-Drape Wound Protector
Published
2016-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EYFPROTECTOR, WOUND, PLASTIC
KGWRing (wound protector), drape retention, internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYFProtector, Wound, PlasticGeneral, Plastic Surgery1
KGWRing (Wound Protector), Drape Retention, InternalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380064348PackageGS140In Commercial Distribution
10885380064340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538006434850885380064348
1088538006434010885380064340

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Regulatory Flags#

DUNS number
961027315
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
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

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
00810132043956HCSConcordance Healthcare Solutions LLCEYF2025-03-04
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
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