AccessGUDID - DEVICE: FuStarTM Steerable introducer (06938370117070)

GUDID

Device Identifier (DI) Information

Brand Name: FuStarTM Steerable introducer
Version or Model: SLA6F-550
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lifetech Scientific (Shenzhen) Co., Ltd.

Primary DI Number: 06938370117070
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529864170 *Terms of Use

Device Description: The FuStarTM Steerable Introducers are designed to perform as a guiding shealth and/or introducer sheath, which provides a pathway through whichdevices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low-profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of cathelters and devices. The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm(Large). Ineach option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination Also, the visible knob with scale of controller facillitates the physicians to estimate the deflecting angle of the sheath while intra-operation. The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French sie, 5F, 6F, 7F, 8F, 9F and 10F). The deflection angle of shealth is from 0 degree to 180 degree.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45419	Cardiac occluder delivery kit	A collection of devices designed to implant a cardiac occluder (not included) for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravascular delivery and deployment of a cardiac occluder. The devices are used in the treatment of cardiac disorders that may include atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100184	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df86d80f-fca8-4b89-b7f4-7b2004a40909
Public Version Date: February 19, 2021
Public Version Number: 4
DI Record Publish Date: November 06, 2017