FDA.reportPublic FDA data

APLICOR 3D

Primary DI
08809692501015
Brand
APLICOR 3D
Company
ROKIT HEALTHCARE Inc.
Model
4D2D101
Published
2024-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809692501012PackageGS11In Commercial Distribution
08809692501015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880969250101218809692501012
08809692501015088096925010158809692501015

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory liquid dispenser, electronicAn electronic laboratory device designed to dispense fluid from a stock reservoir (e.g., a bottle or other container). The intended volume is normally user-selected prior to the delivery of the liquid. The device typically has a peristaltic pump for delivery of the preselected volume that typically ranges from 1 ml to 9.99 L. This device can be user operated, automatic, or programmable.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689004656
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809692500285Dr.INVIVO4D2D1012026-04-02
08809692500117APLICOR 3D KIT, Dr. INVIVO Scaffold KITSK-0012024-10-04
08809692500131APLICOR 3D KIT, Dr. INVIVO Scaffold KITSK-0032024-10-04
08809692500124APLICOR 3D KIT, Dr. INVIVO Scaffold KITSK-0022024-10-04
08809692507000AiD RegenAIDR-0012024-11-14
00889692500117APLICOR 3D KIT, Dr. INVIVO Scaffold KITSK-0012024-10-04
00889692500124APLICOR 3D KIT, Dr. INVIVO Scaffold KITSK-0022024-10-04
00889692501015APLICOR 3D, Dr. INVIVO4D2D1012024-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30813360023654UnoDoseCordica Medical, Inc.KYX2026-10-22
40813360023651UnoDoseCordica Medical, Inc.KYX2026-10-22
10813360023643UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023674UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023681UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023640UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023657UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023671UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023688UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023647UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023678UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023685UnoDoseCordica Medical, Inc.KYX2026-10-20
40813360023644UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023667UnoDoseCordica Medical, Inc.KYX2026-10-06
20813360023664UnoDoseCordica Medical, Inc.KYX2026-10-06
30813360023661UnoDoseCordica Medical, Inc.KYX2026-10-06
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22