FDA.reportPublic FDA data

BAYONET SPINAL KNIFE HANDLE

Primary DI
00192896078567
Brand
BAYONET SPINAL KNIFE HANDLE
Company
SONTEC INSTRUMENTS, INC.
Model
400-428
Catalog number
400-428
Device description
BAYONET SPINAL KNIFE HANDLE #3
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
EMFKNIFE, SURGICAL
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896078567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896078567001928960785671928960785670192896078567

GMDN Terms#

Term, Definition table
TermDefinition
Haemostatic knifeA hand-operated surgical instrument, similar in appearance to a surgical scalpel, designed for simultaneous cutting of tissues and cauterization (haemostasis) of blood vessels by applying an electrically-heated blade. It typically consists of a high-resistance, flat, sharp blade at the distal end and a handle at the proximal end with an electric cable; the blade is typically an integral part of the knife. Haemostasis is induced by direct transmission of thermal energy (heat) from the blade to the tissues; negating the use of grounding electrodes. It is used for a variety of procedures, including general and plastic surgery, gynaecology, and orthopaedics. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length13.75Inch

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam 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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Primary DI, Brand, Company table
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