FDA.reportPublic FDA data

Bristle needles

Primary DI
28657300002201
Brand
Bristle needles
Company
AP MEDESTHETICS, INC.
Model
27G, 33G
Device description
The single piece device is a plastic handle fused to a stainless-steel needle, insulated to the tip. The other end of the plastic handle is fused to a flexible lead wire and a “touch-proof” safety connector. The device is used to transfer RF energy from the VeinGogh generator to the spider vein.
Published
2019-06-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112426000XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBESXian Friendship Medical Electronics Co., Ltd.2012-04-02ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28657300002201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2865730000220128657300002201

GMDN Terms#

Term, Definition table
TermDefinition
Intracutaneous electrosurgical probeA sterile, hand-held surgical instrument intended to be introduced into the dermal layer of a patient’s skin (intradermal) to deliver radio-frequency current in a monopolar configuration from a system generator to coagulate/ablate superficial skin lesions (e.g., telangiectasia, cherry angioma, venous lake, skin tags). It is comprised of an insulated handle with a thin, distal, monopolar electrode. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056296605
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18657300002204Bristle needles27G, 33G2019-06-06
86573000022001Bristle needles27G, 33G2019-01-17
86573000021011VeinGogh1012016-12-22

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