FDA.reportPublic FDA data

OFIX

Primary DI
17540279100020
Brand
OFIX
Company
Icentia Inc.
Model
10-002
Device description
OFIX adhesive disks
Published
2024-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540279100020PrimaryGS10
17540279001020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754027910002017540279100020
1754027900102017540279001020

GMDN Terms#

Term, Definition table
TermDefinition
Cable/lead/sensor non-conductive skin-adherent patchAn adhesive, non-conductive patch/pad intended to secure a cable/lead/sensor used during a medical procedure [e.g., cardiopulmonary resuscitation (CPR) sensor, ECG lead, phototherapy unit cable] to the skin of a patient. It has no electrical or conducting components or properties and is made of synthetic polymer materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
241983607
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17540279200027CardioSTAT10-0062025-12-08
17540279105018EART10-5012024-03-26
27540279250029CardioSTAT10-0062024-12-18
27540279250074CardioSTAT10-0062024-12-18
27540279250142CardioSTAT10-0062024-12-18
17540279200072CardioSTAT10-0062024-03-26
17540279200140CardioSTAT10-0062024-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586487Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07