FDA.reportPublic FDA data

APLICOR 3D KIT, Dr. INVIVO Scaffold KIT

Primary DI
00889692500117
Brand
APLICOR 3D KIT, Dr. INVIVO Scaffold KIT
Company
ROKIT HEALTHCARE Inc.
Model
SK-001
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
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
00889692500117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889692500117008896925001178896925001170889692500117

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689004656
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
08809692500285Dr.INVIVO4D2D1012026-04-02
08809692501015APLICOR 3D4D2D1012024-10-04
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
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
18859299184705SMARTeZ Fluid Transfer SetEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKYX2026-04-08
08809692500285Dr.INVIVOROKIT HEALTHCARE Inc.KYX2026-04-02
00008279897857Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
30827989000354Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-09-16
10827989003924Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003931Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003948Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003955Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989000381Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989000404Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003429Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003801Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-20
10827989000398Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-03
10827989004167Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-03
10827989000336Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000343Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000350Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000770Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004044Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004051Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004068Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989001098Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001128Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001159Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001180Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001210Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001241Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001272Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001302Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001333Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16