AccessGUDID - DEVICE: STRADIS (M7525250271)

GUDID

Device Identifier (DI) Information

Brand Name: STRADIS
Version or Model: 525-027
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 525-027
Company Name: STRADIS MEDICAL, LLC

Primary DI Number: M7525250271
Issuing Agency: HIBCC
Commercial Distribution End Date: May 04, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 174262477 *Terms of Use

Device Description: INTRODUCER KIT, 4FRX20CM GW .018"X70CM MANDREL 21GX2.75 ECHO NEEDLE ONE STEP 10/BX

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
DRE	Dilator, Vessel, For Percutaneous Catheterization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K780126	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
Catheter Gauge: 4 French
Needle Gauge: 21 Gauge
Length: 20 Centimeter

Device Record Status

Public Device Record Key: ba7d868c-e4ad-4169-b972-401570260332
Public Version Date: March 20, 2024
Public Version Number: 5
DI Record Publish Date: May 04, 2016