AccessGUDID - DEVICE: EcoBalloon DIL-BI (14048223008642)

GUDID

Device Identifier (DI) Information

Brand Name: EcoBalloon DIL-BI
Version or Model: 1285-50-11
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1285-50-11
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223008642
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-BI Bilateral 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?
44794	Surgical balloon dissector	A device used to dissect connective tissue layers creating access to a surgical site for a variety of surgical procedures. The device typically consists of a cannula, a distention balloon, an obturator, an inflation bulb, and a regulating valve(s). An endoscope is introduced into the cannula to monitor the dissection and/or the insertion process. The balloon is inflated to fill volume exerting pressure on the tissue layers. It is then deflated and removed, and distention is maintained by infusion of carbon dioxide (CO2) via the cannula. This device can be used for hernia repair, varicocele dissection, sympathectomy, lymph node biopsy, or perforator vein ligation. 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: 2b9f7b93-66ab-4b11-ab6d-3d7ff2091296
Public Version Date: March 17, 2025
Public Version Number: 3
DI Record Publish Date: April 16, 2019