FDA UDI Not in Commercial Distribution 🇺🇸 United States

Bristle needles

DI: 18657300002204 · Model: 27G, 33G · AP MEDESTHETICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Bristle needles
Primary DI
18657300002204
Version / Model
27G, 33G
Company Name
AP MEDESTHETICS, INC.
Labeler DUNS
056296605
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-06-06
Public Version
4
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
89c6962c-9349-4d63-8d90-6ff57d9f2f52
Distribution End Date
2019-11-27

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.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GXZ Electrode, Needle

GMDN Terms

Code Name
63686 Intradermal radio-frequency ablation system probe

Identifiers

Type ID
Primary 18657300002204