AccessGUDID - DEVICE: Stradis Medical, LLC. (M752525038R10)

GUDID

Device Identifier (DI) Information

Brand Name: Stradis Medical, LLC.
Version or Model: 525-038 R1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: STRADIS MEDICAL, LLC

Primary DI Number: M752525038R10
Issuing Agency: HIBCC
Commercial Distribution End Date: January 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 174262477 *Terms of Use

Device Description: 5FR Micro-Introducer Kit

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
OFL	Percutaneous Sheath Introducer Kit

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 52cff24c-f20a-4d4f-a2d1-a68afe7bcdf3
Public Version Date: March 20, 2024
Public Version Number: 5
DI Record Publish Date: April 12, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M752525038R13	5	M752525038R10	2023-01-04	Not in Commercial Distribution	inner carton
M752525038R15	20	M752525038R13	2023-01-04	Not in Commercial Distribution	outer box