FDA.report

CHUCK HANDLE

Primary DI
00192896019690
Brand
CHUCK HANDLE
Company
SONTEC INSTRUMENTS, INC.
Model
19-1820
Catalog number
19-1820
Device description
CHUCK HANDLE ROUND
Published
2018-09-12
Public version status
Update
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
GDZHandle, Scalpel
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications

CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896019690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896019690001928960196901928960196900192896019690

GMDN Terms

TermDefinition
Ophthalmic surgical instrument handle, manualA hand-held manual device designed to hold and operate a compatible ophthalmic surgical instrument tip (typically scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a manually-operated internal actuating piston that operates the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue; it is not a handle for a corneal trephine. This is a reusable device.

Device Sizes

TypeValueUnit
Length7.5Centimeter

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(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
false
Sterilization required before use
true

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