AccessGUDID - DEVICE: Novell Adjustable Curve Suction Irrigation Accessory Long (10860010625405)

GUDID

Device Identifier (DI) Information

Brand Name: Novell Adjustable Curve Suction Irrigation Accessory Long
Version or Model: REF 4201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REF 4201
Company Name: Platform Innovations Inc.

Primary DI Number: 10860010625405
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119045488 *Terms of Use

Device Description: No description.

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:	No
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?
34923	Suction system catheter, general-purpose	A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOL	Catheter And Tip, Suction

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: 880ced9a-71c0-4f9b-9a38-66a17bfbb0cc
Public Version Date: October 09, 2023
Public Version Number: 3
DI Record Publish Date: September 15, 2023