FDA.reportPublic FDA data

RHOTON PICK

Primary DI
00192896036567
Brand
RHOTON PICK
Company
SONTEC INSTRUMENTS, INC.
Model
413-012S
Catalog number
413-012S
Device description
RHOTON PICK STRAIGHT SEMI SHARP TIP STAINLESS STEEL
Published
2018-09-13
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
GDIDissector, Surgical, General & Plastic Surgery
GDMNEEDLE, ASPIRATION AND INJECTION, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896036567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896036567001928960365671928960365670192896036567

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, reusableA flexible sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.5Inch

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

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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