FDA.reportPublic FDA data

FANOUS SABERBACK SCISSORS

Primary DI
00192896054882
Brand
FANOUS SABERBACK SCISSORS
Company
SONTEC INSTRUMENTS, INC.
Model
1200-387
Catalog number
1200-387
Device description
FANOUS SABERBACK SCISSORS CURVED TENOTOMY TIP POWER CUT GOLD
Published
2018-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBDScissors, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBDScissors, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896054882PrimaryGS10
00192896099593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896054882001928960548821928960548820192896054882
00192896099593001928960995931928960995930192896099593

GMDN Terms#

Term, Definition table
TermDefinition
Nasal scissorsA hand-held, manual, surgical instrument used to cut tissue during ear/nose/throat (ENT) or plastic surgery in or on the nose and its associated structures. It comprises two 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, usually having slender, pointed blades set at an angle to the handles. Some types can have carbide inserts along the cutting edges. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.5Inch

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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00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
00192896025943MEYERDING RETRACTOR207-415207-4152018-09-12
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