FDA.reportPublic FDA data

Introducer D3.5 mm, 167 mm, Trocar.

Primary DI
07290015487139
Brand
Introducer D3.5 mm, 167 mm, Trocar.
Company
ICECURE MEDICAL LTD
Model
FAC9200000
Catalog number
FAC9200000
Device description
Consists of Mandrel (FAC9200000-1) and Cannula (FAC9200000-2)
Published
2019-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDFGuide, Needle, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290015487136PackageGS11In Commercial Distribution
07290015487139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001548713617290015487136
07290015487139072900154871397290015487139

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter3.5Millimeter
Shaft Length167Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+16468443066icecuresupport@icecure-medical.com
18889025716icecuresupport@icecure-medical.com

Regulatory Flags#

DUNS number
514758619
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015487290PROSENSE™ SYSTEM 100-127 VACFAS3000000-2FAS3000000-22021-08-11
07290015487160PROSENSE™ SYSTEM 100-127 VACFAS3000000FAS30000002019-10-24
07290015487061Temperature SensorFAT8000000FAT80000002022-06-07
07290015487542Cryoprobe CP-20040592025-05-06
07290015487535CryoprobeCP-20040582025-05-06
17290015487549Cryoprobe CP-20040592025-05-06
07290015487511XSense Cryoablation SystemCSS-20040542025-05-05
07290015487528External 25L DewarCSS-20040552025-05-05
07290015487115Introducer D2.5 mm, 115 mm, Trocar. FAC9000000FAC90000002019-10-24
07290015487122Introducer D3.5 mm, 122 mm, Trocar. FAC9100000FAC91000002019-10-24
07290015487023Cryoprobe D3.4 mm/10G, 127 mm, Trocar, Spheric.FAP7100000FAP71000002019-10-24
07290015487030Cryoprobe D3.4 mm/10G, 140 mm, Trocar, Elliptic.FAP7200000FAP72000002019-10-24
07290015487047Cryoprobe D2.4 mm/13G, 124 mm, Trocar, Spheric.FAP7600000FAP76000002019-10-24
07290015487054Cryoprobe D2.4 mm/13G, 134 mm, Trocar, Elliptic.FAP7800000FAP78000002019-10-24
07290015487085Cryoprobe D3.4 mm/10G, 185 mm, Trocar, Elliptic.FAP7410000FAP74100002019-10-24
07290015487153HolderFAG3000000FAG30000002023-01-19
07290015487092Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic.FAP7400000FAP74000002019-10-24
07290015487078Cryoprobe D2.4 mm/13G, 180 mm, Trocar, Elliptic.FAP7820000FAP78200002019-10-24
07290015487108Cryoprobe D3.4 mm/10G, 285 mm, Pencil, Elliptic.FAP7910000FAP79100002019-10-24

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Primary DI, Brand, Company table
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07630037864585APTUSMedartis AGGDF2025-04-08
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