AccessGUDID - DEVICE: STRADIS HEALTHCARE (M7526822138NL10)

GUDID

Device Identifier (DI) Information

Brand Name: STRADIS HEALTHCARE
Version or Model: 682-2138NL1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: STRADIS MEDICAL, LLC

Primary DI Number: M7526822138NL10
Issuing Agency: HIBCC
Commercial Distribution End Date: February 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 174262477 *Terms of Use

Device Description: Custom Surgical Vein Pack

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":	Yes
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?
33961	General surgical procedure kit, non-medicated, single-use	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEZ	Cardiovascular Procedure Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 309d79df-2eb0-4a84-b0df-a108a19c6b72
Public Version Date: February 07, 2023
Public Version Number: 4
DI Record Publish Date: March 15, 2022