EcoBalloon DIL-XL

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name: EcoBalloon DIL-XL FDA UDI
Generic Name: Laparoscopic access cannula anchor, single-use FDA UDI
Device Name: EcoBalloon DIL-XL Unilateral dilatation balloon Ø 11mm for extraperitoneal surgery FDA UDI
Model / Reference: 1285-60-11 FDA UDI
Description: EcoBalloon DIL-XL Unilateral dilatation balloon Ø 11mm for extraperitoneal surgery FDA UDI

Identifiers

Catalog Number: 1285-60-11 FDA UDI
Primary DI / UDI-DI: 04048223133026 FDA UDI
510(k) Number: K090631 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Laparoscopic access cannula anchor, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laparoscopic access cannula anchor, single-use

EcoBalloon DIL-XL by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic access cannula anchor, single-use.

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Thoracoport — Covidien LP · Class II
TiLink-P Anchor — SURGENTEC LLC · Class II
TiLink-P Screw 12mm x 25mm — SURGENTEC LLC · Class II
TiLink-L Implant 35mm x 10mm — SURGENTEC LLC · Class II
TiLink-L Implant 30mm x 10mm — SURGENTEC LLC · Class II
Thoracoport — Covidien LP · Class II
Thoracoport — Covidien LP · Class II

Cleared under the same submission

K090631 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Pajunk GmbH Medizintechnologie

Sources (1)

FDA UDI d36eb4c2-5c5d-43ca-b965-fc9e3c07c4f8 37 fields · synced May 30, 2026