AccessGUDID - DEVICE: ECO BALLOON DIL-BI (04048223057971)

GUDID

Device Identifier (DI) Information

Brand Name: ECO BALLOON 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: 04048223057971
Issuing Agency: GS1
Commercial Distribution End Date: June 17, 2025
Device Count: 5
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 14048223008642

Device Description: 1285-50-11

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b181ce20-b908-4e08-ab7f-314450790c99
Public Version Date: June 17, 2025
Public Version Number: 5
DI Record Publish Date: April 02, 2021