AccessGUDID - DEVICE: CUTTING INTRODUCER (04048223116180)

GUDID

Device Identifier (DI) Information

Brand Name: CUTTING INTRODUCER
Version or Model: 1206-19120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1206-19120
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223116180
Issuing Agency: GS1
Commercial Distribution End Date: June 17, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 04048223056509

Device Description: 1206-19120

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):	No
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?
46328	Simple pneumoperitoneum needle	A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

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
Storage Environment Humidity: between 10 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7070b15e-97d0-4c07-9b2a-43e237e30b21
Public Version Date: June 17, 2025
Public Version Number: 3
DI Record Publish Date: July 07, 2021