FDA.reportPublic FDA data

NA

Primary DI
ESOT009111
Brand
NA
Company
S & T AG
Model
JFCL-3-18D.2
Catalog number
00911
Device description
JFCL-3-18d.2 Vessel Dilator, 18 cm long, flat 9 mm, curved, tip 0.2 mm
Published
2022-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESOT009111PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41526727407info@s-and-t.net

Regulatory Flags#

DUNS number
481542926
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ESOT010801NACB-1.A010802026-01-20
ESOT000801NACB-1000802022-09-15
ESOT010751NAICL-1323-0.A010752023-03-01
ESOT011851NAICH-1323-0.A011852023-03-01
ESOT000711NACAF-4 L000712022-09-15
ESOT000721NACAF-4000722022-09-15
ESOT000731NACAF-5 L000732022-09-15
ESOT000741NACAF-5000742022-09-15
ESOT000751NAICL-1323-0000752022-09-15
ESOT000761NAICE-2427-0000762022-09-15
ESOT000821NAB-13-10000822022-09-15
ESOT000831NABL-13-10000832022-09-15
ESOT000841NAB-13-8000842022-09-15
ESOT000851NABL-13-8000852022-09-15
ESOT000861NAB-18-10000862022-09-15
ESOT000871NAB-18-8000872022-09-15
ESOT000881NAC-14000882022-09-15
ESOT000891NACL-14000892022-09-15
ESOT000901NASDC-11000902022-09-15
ESOT000911NASDC-15000912022-09-15

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