FDA.reportPublic FDA data

SONTEC NASAL TIP CARTILAGE PUNCH

Primary DI
00192896042643
Brand
SONTEC NASAL TIP CARTILAGE PUNCH
Company
SONTEC INSTRUMENTS, INC.
Model
475-729
Catalog number
475-729
Device description
SONTEC NASAL TIP CARTILAGE PUNCH WITH HANDLE HEART SHAPED TIP
Published
2018-09-14
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
KTFPUNCH, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTFPunch, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896042643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896042643001928960426431928960426430192896042643

GMDN Terms#

Term, Definition table
TermDefinition
ENT punchA general-purpose, manual surgical instrument designed for taking a soft tissue or bone sample during ear/nose/throat (ENT) surgery. It is typically designed with a long, thin, two-part sliding shaft (the upper part sliding along the lower part) which is joined to sprung (self-opening), pivoted, pistol-grip or ring handles. The working end terminates with sharp, profiled cutting jaws that close over the tissue when the handles are squeezed together cutting through it. It is available in various sizes and designs and is made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch

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
Lot or batch
true
Sterilization required before use
true

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