FDA.reportPublic FDA data

SONTEC OPERATING LARYNGOSCOPE SUCTION TUBE

Primary DI
00192896080355
Brand
SONTEC OPERATING LARYNGOSCOPE SUCTION TUBE
Company
SONTEC INSTRUMENTS, INC.
Model
485-1341
Catalog number
485-1341
Device description
SONTEC OPERATING LARYNGOSCOPE SUCTION TUBE
Published
2018-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery
JZFTUBE, EAR SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896080355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896080355001928960803551928960803550192896080355

GMDN Terms#

Term, Definition table
TermDefinition
Tonsil suction cannulaA long metal tube that is attached to a suction system and manipulated by the surgeon for the evacuation (suctioning) of blood, fluids, and other tissue debris from the surgical site during a tonsillectomy or other oral and laryngeal surgical procedures. This is a dedicated device that typically attaches to a dedicated handpiece and a suction system. Its distal end will typically be curved to facilitate its application within the oral cavity and throat and may include multiple apertures to negate the problem of the suction being to aggressive (i.e., the tip grabbing at the tissue). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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