AccessGUDID - DEVICE: Biotronik Fortress Introducer Sheath System (04251244500023)

GUDID

Device Identifier (DI) Information

Brand Name: Biotronik Fortress Introducer Sheath System
Version or Model: 100 cm, 4F Straight
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 358815
Company Name: Contract Medical International GmbH

Primary DI Number: 04251244500023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330926895 *Terms of Use

Device Description: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	Introducer, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100799	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
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 1.62 Millimeter
Length: 100 Centimeter

Device Record Status

Public Device Record Key: 3d19c68b-ef61-4018-810a-f004adcd64db
Public Version Date: March 20, 2024
Public Version Number: 6
DI Record Publish Date: June 30, 2016