FDA.reportPublic FDA data

CANNULA

Primary DI
00192896094314
Brand
CANNULA
Company
SONTEC INSTRUMENTS, INC.
Model
2700-754
Catalog number
2700-754
Device description
CANNULA STRAIGHT OLIVE TIP
Published
2019-03-07
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
GDMNEEDLE, ASPIRATION AND INJECTION, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896094314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896094314001928960943141928960943140192896094314

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy needle, reusableA rigid device intended to be used to obtain tissue specimens, for histopathological examination, during various endoscopic procedures (e.g., bronchoscopy, gastroscopy). It is typically constructed of a rigid metal tube whose distal end is equipped with a biopsy needle which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the compatible endoscope. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length2Inch
Needle Gauge18Gauge

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
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

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