AccessGUDID - DEVICE: DuraSheath Introducer Sheath System (04251244500122)

GUDID

Device Identifier (DI) Information

Brand Name: DuraSheath Introducer Sheath System
Version or Model: 4F, 90cm, straigth
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-04090
Company Name: Contract Medical International GmbH

Primary DI Number: 04251244500122
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 One (1) dilator.

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:	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 [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Keep away from direct sunlight
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Length: 90 Centimeter
Lumen/Inner Diameter: 1.60 Millimeter

Device Record Status

Public Device Record Key: 38e3f2ae-932a-4155-b9d1-ea5a89de3282
Public Version Date: March 20, 2024
Public Version Number: 3
DI Record Publish Date: June 30, 2019