FDA.reportPublic FDA data

eCoin Aftercare Kit

Primary DI
00860007896941
Brand
eCoin Aftercare Kit
Company
Valencia Technologies Corporation
Model
1011-2813
Device description
eCoin Aftercare Kit
Published
2022-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OXQDressing Change Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007896941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007896941008600078969418600078969410860007896941

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
968538988
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007896972eCoin External Controller Kit1011-54361011-54362023-04-27
00860007896903eCoin Device Kit1011-24471011-24472022-04-28
00860007896910eCoin External Controller Kit1011-17522022-04-28
00860007896927eCoin Procedural Kit1011-27002022-04-28
00860007896958eCoin Explant Kit1011-42622022-04-28
00860007896965eCoin Patient Kit1011-19012022-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956538856CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956539617CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956556744CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956564367CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10653160394600MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-08-27
10198956541474CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26
10198956548701CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26
10198956557758CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26
10653160394358MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-08-26
10198956539358CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-18
10198956499348CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-17
10198956538511CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-17
10198956490895CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-31
10198956339019CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-27
10198956467408CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-27
10198956514348CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-27
10198956520622CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-27
10198956523654CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-27
10198956524248CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-27
10653160391326MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-24
10653160393979MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394051MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394082MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394112MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394129MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394181MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394211MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10198956334281CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-20
10198956500518CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-20
10198956504097CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-20