FDA.report

GOLDMAN FOX SCISSORS

Primary DI
00192896097445
Brand
GOLDMAN FOX SCISSORS
Company
SONTEC INSTRUMENTS, INC.
Model
1200-404
Catalog number
1200-404
Device description
GOLDMAN FOX SCISSORS STRAIGHT BLADE POWER CUT GOLD
Published
2019-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KBDScissors, Nasal

Product Code Classifications

CodeDeviceSpecialtyClass
KBDScissors, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896097445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896097445001928960974451928960974450192896097445

GMDN Terms

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

TypeValueUnit
Length5Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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