FABINJECT LLC

Registration Details

Registration Name: FABINJECT LLC
Registration Number: 3030979014
FEI Number: 3030979014
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 7006 Stapoint Ct Ste I
City: Winter Park
State: FL
ZIP: 32792
Country: US

Regulatory Submissions

510(k) Number: K242132

Owner / Operator

Firm Name: Fabinject LLC
Operator Number: 10090611
Address: 7006 Stapoint Ct Ste I
City: Winter Park
State: FL
Postal Code: 32792
Country: US
Correspondent: Gianmaria Cominata Filho

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Powered Laser Surgical Instrument	GEX	Class 2	General, Plastic Surgery	No	2024-10-23
Pack, Hot Or Cold, Reusable	IME	Class 1	Physical Medicine	No	2024-04-30
Cannula, Surgical, General & Plastic Surgery	GEA	Class 1	General, Plastic Surgery	No	2024-05-30
Transilluminator, Battery-Powered	HJN	Class 1	Ophthalmic	No	2024-04-18

Proprietary Names

FREDDO Skin Cooler - Pen Skin Cooler Roller - Small Skin Cooler Roller - Large D 24G-120 B 23G-60 B 19G-40 D 16G-100 B 27G-120 B 26G-30 B 20G-100 B 30G-19 D 23G-100 B 17G-50 B 27G-50 B 16G-38 D 22G-50 D 17G-40 B 18G-50 B 27G-80 B 19G-16 B 21G-37 B 29G-16 D 22G-19 D 22G-90 B 28G-32 B 28G-38 B 19G-70 D 29G-19 B 29G-70 B 17G-32 B 30G-60 D 16G-25 D 27G-120 D 18G-120 B 23G-37 B 22G-60 B 20G-50 D 24G-38 D 20G-80 B 15G-100 B 26G-19 D 28G-38 B 17G-37 D 23G-90 B 21G-100 B 22G-40 D 23G-70 B 25G-57 B 27G-90 B 30G-38 D 17G-57 B 20G-60 D 19G-30 B 16G-80 D 20G-50 B 30G-80 D 17G-16 B 24G-40 B 30G-120 B 27G-57 D 22G-60 D 22G-100 D 23G-25 B 21G-38 B 30G-50 D 18G-80 D 27G-38 D 21G-80 B 24G-13 B 21G-90 D 17G-32 B 16G-110 B 25G-110 D 21G-19 B 24G-55 D 17G-37 B 26G-13 D 22G-32 D 30G-25 D 29G-38 B 29G-120 D 25G-32 B 23G-13 D 26G-16 D 18G-32 B 17G-16 B 21G-110 B 20G-25 D 21G-120 D 26G-110 B 16G-70 D 29G-57 D 24G-32 B 30G-32 D 15G-80 D 27G-25 D 15G-30 B 24G-37 B 26G-80 B 18G-38 D 21G-37 D 27G-70 D 23G-29 B 27G-19 B 18G-110 D 29G-70 D 19G-110 B 18G-120 D 17G-90 D 22G-57 D 20G-38 B 25G-50 B 21G-16 B 25G-70 B 16G-40 D 22G-16 D 16G-110 D 20G-16 D 15G-110 D 25G-16 B 29G-60 D 26G-19 B 27G-40 D 23G-80 D 27G-19 D 27G-13 B 20G-90 D 18G-38 B 23G-29 D 20G-100 B 21G-25 B 29G-25 B 30G-40 D 18G-70 B 24G-57 D 25G-110 B 27G-25 D 30G-30 B 22G-13 B 28G-60 D 30G-70 B 22G-120 D 21G-57 D 25G-70 D 26G-100 B 30G-70 D 20G-110 B 22G-38 B 23G-57 D 20G-70 B 22G-110 D 26G-32 B 15G-70 D 28G-32 B 26G-60 D 28G-100 B 20G-13 D 28G-90 B 20G-19 D 23G-32 D 15G-100 B 17G-90 D 20G-13 D 23G-120 B 26G-16 B 27G-30 B 27G-16 B 17G-38 B 23G-32 B 23G-30 B 17G-25 D 18G-50 B 22G-32 B 21G-32 B 29G-90 B 18G-13 D 28G-57 B 23G-80 B 25G-13 B 17G-70 B 25G-30 D 19G -100 B 24G-30 B 23G-25 B 22G-19 D 19G-60 B 19G-120 D 19G-70 D 22G-30 D 26G-120 B 18G-30 B 27G-13 B 27G-32 B 26G-40 B 25G-32 B 27G-37 B 23G-19 B 29G-57 D 21G-70 B 28G-120 D 23G-37 B 18G-37 B 15G-30 D 24G-40 D 23G-30 D 22G-40 D 23G-40 B 20G-38 Fabinject Micro Cannula Slim Blunt (B) D 22G-13 B 20G-110 B 30G-90 D 25G-90 B 26G-38 B 26G-37 B 18G-25 B 18G-19 D 29G-120 B 24G-60 B 30G-100 D 26G-70 D 16G-38 D 30G-13 B 29G-38 D 21G-100 D 27G-40 B 24G-32 D 19G-19 D 18G-40 B 27G-60 B 18G-32 B 27G-70 D 22G-38 D 27G-90 B 26G-90 B 22G-70 B 19G-19 B 21G-57 D 28G-60 B 20G-57 D 30G-110 B 30G-24 B 29G-80 D 17G-13 D 28G-30 D 28G-25 D 23G-60 D 17G-38 B 23G-38 D 21G-110 B 20G-37 D 21G-25 D 30G-19 D 19G-13 B 23G-90 D 28G-50 B 28G-50 B 17G-80 D 20G-37 D 30G-50 D 26G-13 B 18G-40 B 19G-60 D 23G-57 B 21G-40 B 27G-100 D 19G-90 D 27G-50 D 16G-80 D 19G-16 D 24G-30 B 29G-50 D 24G-16 D 30G-38 D 26G-30 B 22G-30 D 30G-80 B 22G-50 B 26G-100 D 27G-60 D 26G-60 B 18G-100 D 15G-70 D 24G-25 B 25G-16 B 19G -100 D 18G-30 B 24G-16 B 15G-50 B 28G-80 B 24G-50 B 23G-100 D 17G-50 D 23G-50 D 28G-70 D 21G-16 D 30G-32 D 30G-24 D 26G-25 D 26G-40 D 19G-25 B 26G-70 B 26G-57 B 29G-13 B 20G-30 B 25G-100 B 24G-70 D 26G-38 D 17G-100 D 28G-110 B 21G-80 D 20G-90 D 29G-50 D 18G-16 D 24G-90 D 17G-30 D 20G-30 D 27G-80 B 17G-40 D 19G-120 B 29G-32 D 25G-60 D 18G-100 B 24G-90 D 17G-80 D 18G-13 B 19G-57 D 21G-60 B 17G-110 D 28G-16 D 27G-110 B 17G-19 B 25G-38 B 22G-37 B 30G-57 D 23G-19 D 22G-110 D 30G-16 D 29G-80 B 17G-13 D 23G-13 B 30G-25 B 16G-50 D 19G-50 B 18G-70 D 18G-57 B 27G-110 D 21G-30 D 18G-25 D 22G-120 D 25G-57 D 29G-110 B 22G-80 B 22G-25 B 16G-25 B 19G-90 D 21G-50 B 22G-90 B 26G-32 B 26G-25 D 19G-32 D 30G-60 D 21G-32 D 29G-30 D 19G-57 B 28G-90 B 19G-38 D 30G-120 B 21G-60 B 28G-110 B 29G-30 B 24G-110 D 27G-37 D 25G-30 D 28G-120 B 30G-16 B 25G-19 D 18G-19 B 24G-38 B 26G-120 B 21G-30 D 30G-90 D 24G-70 B 28G-100 B 29G-19 D 23G-110 B 15G-80 B 30G-37 B 19G-32 B 17G-100 B 28G-25 B 24G-25 B 22G-16 B 28G-70 B 23G-120 D 16G-40 D 23G-38 D 24G-60 D 24G-57 D 28G-80 D 24G-19 B 26G-110 D 17G-70 B 17G-57 B 24G-100 D 22G-70 B 23G-16 D 16G-30 D 29G-100 B 16G-100 D 29G-16 D 19G-38 B 16G-30 D 26G-80 B 29G-110 D 26G-57 D 24G-50 D 26G-50 B 19G-13 D 25G-19 B 17G-45 B 20G-80 D 27G-100 B 19G-80 B 15G-110 D 22G-37 D 21G-40 D 25G-80 D 20G-40 B 20G-40 B 28G-13 D 29G-90 D 22G-25 B 25G-90 D 24G-13 D 26G-37 D 25G-25 B 26G-50 D 17G-19 D 25G-13 D 20G-32 B 23G-40 D 17G-45 B 23G-50 D 27G-57 D 25G-50 D 21G-13 D 16G-70 B 24G-80 B 28G-19 D 21G-90 D 27G-16 D 24G-80 Fabinject Micro Cannula Slim Duckbill (D) B 25G-120 D 20G-60 D 20G-25 D 18G-37 D 30G-57 B 30G-110 D 15G-50 B 23G-70 D 17G-60 B 28G-16 D 25G-100 B 30G-30 B 21G-120 B 25G-40 D 30G-37 D 22G-80 D 17G-25 B 17G-60 D 24G-55 B 17G-30 D 29G-13 B 21G-50 D 25G-37 D 25G-120 D 24G-37 D 30G-100 D 25G-40 B 22G-100 D 19G-40 D 27G-32 B 24G-120 B 28G-57 D 20G-19 D 21G-38 B 19G-30 B 28G-30 B 29G-100 B 21G-70 B 30G-13 D 18G-90 D 29G-60 D 30G-40 D 28G-19 B 25G-25 D 29G-32 B 19G-110 B 25G-60 B 21G-19 B 20G-16 D 19G-80 D 17G-110 B 19G-25 B 18G-16 B 18G-80 D 23G-16 D 27G-30 B 27G-38 B 18G-57 B 25G-37 B 24G-19 D 24G-100 D 26G-90 B 23G-110 D 18G-60 B 20G-32 D 25G-38 B 25G-80 D 18G-110 B 22G-57 D 24G-110 D 20G-57 B 20G-70 B 18G-90 B 18G-60 B 21G-13 D 29G-25 B 19G-50 D 28G-13 D 16G-50 VF1000 Vein Locator

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device