Identity
- Trade Name
- MonoBalloon DIL-XL FDA UDI
- Generic Name
- Surgical balloon dissector FDA UDI
- Device Name
- MonoBalloon DIL-XL Unilateral dilatation balloon Ø11mm round, Extra Large FDA UDI
- Model / Reference
- 1284-60-11 FDA UDI
- Description
- MonoBalloon DIL-XL Unilateral dilatation balloon Ø11mm round, Extra Large FDA UDI
Identifiers
- Catalog Number
- 1284-60-11 FDA UDI
- Primary DI / UDI-DI
- 04048223078235 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Surgical balloon dissector 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: Surgical balloon dissector
MonoBalloon DIL-XL by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical balloon dissector.
- Auto Suture — Covidien LP · Class II
- Auto Suture — Covidien LP · Class II
- EcoBalloon DIL-BI — Pajunk GmbH Medizintechnologie · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI 8cfc2da9-efba-426a-9b5b-dfa443f5f11c 37 fields · synced Jun 8, 2026