AccessGUDID - DEVICE: Cutting introducer cannula for Veress- (14048223008482)

GUDID

Device Identifier (DI) Information

Brand Name: Cutting introducer cannula for Veress-
Version or Model: 1206-19150
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1206-19150
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223008482
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: Cutting introducer cannula for Veress- modular system, sterile, 10 pcs. per box 2,00 x 150 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 938542c3-40b0-4e11-8dcc-87a67a85280e
Public Version Date: March 17, 2025
Public Version Number: 4
DI Record Publish Date: August 30, 2016