AccessGUDID - DEVICE: EcoBalloon DIL-XL (14048223008659)

GUDID

Device Identifier (DI) Information

Brand Name: EcoBalloon DIL-XL
Version or Model: 1285-60-11
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1285-60-11
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223008659
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2025
Device Count: 5
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: EcoBalloon DIL-XL Unilateral dilatation balloon Ø 11mm for extraperitoneal surgery

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":	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?
45342	Laparoscopic access cannula anchor, single-use	A small, sterile, luminal device designed to enable a laparoscopic access cannula (port) to be secured to the skin/tissue of an incision site during a laparoscopic surgical procedure. The outer surface is typically textured/ribbed and intended to grip the tissue whilst the laparoscopic access cannula is inserted through the device lumen and fixed at the required insertion depth using a clamping/locking mechanism. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

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: d1fe9603-ee20-4dfa-adf3-11ef1eb739e9
Public Version Date: March 17, 2025
Public Version Number: 3
DI Record Publish Date: April 16, 2019