FDA.reportPublic FDA data

Bristle needles

Primary DI
86573000022001
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
Published
2019-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
86573000022001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8657300002200186573000022001

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
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
28657300002201Bristle needles27G, 33G2019-06-10
18657300002204Bristle needles27G, 33G2019-06-06
86573000021011VeinGogh1012016-12-22

Other Devices Sharing Product Codes#

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08718375867242NatusTechnomed Engineering B.V.GXZ2021-04-01
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