FDA.report

OFIX

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

Related Records

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
17540279100020PrimaryGS10
17540279001020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1754027910002017540279100020
1754027900102017540279001020

GMDN Terms

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

Regulatory Flags

DUNS number
241983607
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
17540279200027CardioSTAT10-0062025-12-08
27540279250029CardioSTAT10-0062024-12-18
27540279250074CardioSTAT10-0062024-12-18
27540279250142CardioSTAT10-0062024-12-18
17540279105018EART10-5012024-03-26
17540279200072CardioSTAT10-0062024-03-26
17540279200140CardioSTAT10-0062024-03-26

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