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Eco Balloon Trocatec

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
ECO BALLOON TROCATEC FDA UDI
Generic Name
Laparoscopic access cannula seal reducer, single-use FDA UDI
Device Name
1285-13-11 FDA UDI
Model / Reference
1285-13-11 FDA UDI
Description
1285-13-11 FDA UDI

Identifiers

Catalog Number
1285-13-11 FDA UDI
Primary DI / UDI-DI
04048223078372 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Laparoscopic access cannula seal reducer, 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Laparoscopic access cannula seal reducer, single-use

Eco Balloon Trocatec by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic access cannula seal reducer, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pajunk GmbH Medizintechnologie

Sources (1)

  • FDA UDI fd38c9d1-161a-4be4-8268-e1f6935c28d6 36 fields · synced Jun 8, 2026