FDA.reportPublic FDA data

WRIGHT FASCIA NEEDLE

Primary DI
00192896012479
Brand
WRIGHT FASCIA NEEDLE
Company
SONTEC INSTRUMENTS, INC.
Model
10-4600
Catalog number
10-4600
Device description
WRIGHT FASCIA NEEDLE WITH SUTURE EYE SHARP OVAL HOLE TIP
Published
2018-09-11
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
GADRETRACTOR
GDMNeedle, Aspiration And Injection, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896012479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896012479001928960124791928960124790192896012479

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic needle, reusableA slender, straight hollow instrument, with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles; it may also be intended for diagnostic aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length5.5Inch

Sterilization Methods#

Method table
Method
Dry Heat Sterilization;Moist Heat or Steam 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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00192896015272ENUCLEATION SCISSORS13-980513-98052018-09-13
00192896015289ENUCLEATION SCISSORS13-981013-98102018-09-13
00192896015296ENUCLEATION SCISSORS13-982013-98202018-09-13
00192896017214CASTROVIEJO LIP GRAFT CLAMP FORCEPS14-972514-97252018-09-17
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