Identity
- Trade Name
- MonoBalloon URO FDA UDI
- Generic Name
- Laparoscopic access cannula anchor, single-use FDA UDI
- Device Name
- MonoBalloon URO URO ring-anchor balloon Ø 11mm, for extraperitoneal surgery FDA UDI
- Model / Reference
- 1284-70-11S FDA UDI
- Description
- MonoBalloon URO URO ring-anchor balloon Ø 11mm, for extraperitoneal surgery FDA UDI
Identifiers
- Catalog Number
- 1284-70-11S FDA UDI
- Primary DI / UDI-DI
- 04048223078280 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 11.0 Millimeter FDA UDI
Category: Laparoscopic access cannula anchor, single-use
MonoBalloon URO 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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- TiLink-P Anchor — SURGENTEC LLC · Class II
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- 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
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 8db210e2-df51-4300-bdc0-530e82b55df5 37 fields · synced May 30, 2026