FDA.report

NEEDLE ELECTRODE

Primary DI
00192896009271
Brand
NEEDLE ELECTRODE
Company
SONTEC INSTRUMENTS, INC.
Model
A834
Catalog number
A834
Device description
REUSABLE ANGLED FINE NEEDLE ELECTRODE
Published
2018-08-16
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896009271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896009271001928960092711928960092710192896009271

GMDN Terms

TermDefinition
Syringe-loaded injector, electropneumaticA hand-held, mains electricity (AC-powered) and pneumatically-powered (i.e., electropneumatic) device intended to be used in conjunction with a standard plunger syringe and needle for intradermal administration of liquid medications/materials (e.g., dermal reconstructive material), to a preselected depth, in low pre-set doses. It is typically a pistol-shaped device which includes a syringe loading chamber, a mechanism for precise displacement of the syringe plunger, and an adjustable needle guard to define the pre-set injection depth. It is intended to be used by a professional in a professional (e.g., clinical) setting. This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
Device count
1
DM exempt
false
Premarket exempt
false
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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