FDA.reportPublic FDA data

eCoin Explant Kit

Primary DI
00860007896958
Brand
eCoin Explant Kit
Company
Valencia Technologies Corporation
Model
1011-4262
Device description
eCoin Explant Kit
Published
2022-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007896958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007896958008600078969588600078969580860007896958

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968538988
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007896941eCoin Aftercare Kit1011-28132022-04-28
00860007896972eCoin External Controller Kit1011-54361011-54362023-04-27
00860007896903eCoin Device Kit1011-24471011-24472022-04-28
00860007896910eCoin External Controller Kit1011-17522022-04-28
00860007896965eCoin Patient Kit1011-19012022-04-28
00860007896927eCoin Procedural Kit1011-27002022-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956497122CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956498884CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08