FDA.reportPublic FDA data

ARTHROSCOPIC METZENBAUM HOOK SCISSORS

Primary DI
00192896057579
Brand
ARTHROSCOPIC METZENBAUM HOOK SCISSORS
Company
SONTEC INSTRUMENTS, INC.
Model
1271-472
Catalog number
1271-472
Device description
ARTHROSCOPIC METZENBAUM HOOK SCISSORS WITH OVERLOAD CONE RIGHT ANGLED TIP
Published
2018-09-10
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
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896057579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896057579001928960575791928960575790192896057579

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic scissorsA hand-held manual surgical instrument designed to cut bone or cartilage tissue during orthopaedic surgery. It comprises two sturdy pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes. Some types can have carbide inserts along the cutting edges. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length7Inch

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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Primary DI, Brand, Company table
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