AccessGUDID - DEVICE: STORZ (00628725004365)

GUDID

Device Identifier (DI) Information

Brand Name: STORZ
Version or Model: 20400162S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20400162S
Company Name: Canadian Hospital Specialties Limited

Primary DI Number: 00628725004365
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 240992693 *Terms of Use

Device Description: HIGH FLOW INSUFFLATION TUBING WITH FILTER

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?
60839	Microbial medical gas filter, sterile, single-use	A sterile screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia, and/or surgical intervention (e.g., insufflation); it has no additional non-filtering intended uses. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HIF	Insufflator, Laparoscopic

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: 6f4948be-278d-44d5-abf0-09f3f5c24caf
Public Version Date: September 13, 2023
Public Version Number: 3
DI Record Publish Date: August 10, 2016