AccessGUDID - DEVICE: Stradis Medical, LLC. (M7521000161)

GUDID

Device Identifier (DI) Information

Brand Name: Stradis Medical, LLC.
Version or Model: 100016
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: STRADIS MEDICAL, LLC

Primary DI Number: M7521000161
Issuing Agency: HIBCC
Commercial Distribution End Date: February 09, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 174262477 *Terms of Use

Device Description: Pump Supply Kit C

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?
62713	Prefilled mechanical infusion pump/catheter	A device intended to be used in a clinical setting for continuous localized infusion of a dose of analgesic medication (e.g., ropivacaine), using a non-electric/non-elastic mechanical infusion pump, for regional anaesthesia and postoperative pain management. It consists of a mechanical infusion pump prefilled with medication, tubing line, and infusion catheter. The infusion catheter is intended to be inserted into the wound site during surgery and connected to the pump via the tubing line for infusion of the drug. The pump can be worn by the patient during the treatment course. The device is discarded when the medication is exhausted (single-use).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: No
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: 43e2fd8b-1ce9-4997-bf23-b67d7f4dd838
Public Version Date: April 03, 2024
Public Version Number: 3
DI Record Publish Date: October 08, 2018