AccessGUDID - DEVICE: EcoBalloon TrocaTec MAN (04048223032343)

GUDID

Device Identifier (DI) Information

Brand Name: EcoBalloon TrocaTec MAN
Version or Model: 1285-13-11
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1285-13-11
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223032343
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: EcoBalloon TrocaTec MAN TrocaTec with manually and automatically actuated trap-door valve Ø 11mm

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:	No
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?
45597	Laparoscopic access cannula seal reducer, single-use	A small device intended to reduce the sealing diameter of an existing laparoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent laparoscopic sleeve whilst maintaining a seal and inhibiting the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to fit within the laparoscopic access cannula seal (fitted at the proximal end of the cannula) when required throughout the laparoscopic surgical procedure. 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 48b9e85e-1591-434c-a6b8-6784eb5271f5
Public Version Date: March 17, 2025
Public Version Number: 4
DI Record Publish Date: March 08, 2019