Identity
- Trade Name
- NeuroBalloon™ FDA UDI
- Generic Name
- Neural-tissue balloon catheter FDA UDI
- Device Name
- NeuroBalloon™ NEUROBALLOON™ CATHETER FDA UDI
- Model / Reference
- 7CBD10 FDA UDI
- Description
- NeuroBalloon™ NEUROBALLOON™ CATHETER FDA UDI
Identifiers
- Catalog Number
- 7CBD10 FDA UDI
- Primary DI / UDI-DI
- 10381780035343 FDA UDI
- FDA Product Code
- HAO FDA UDI
- GMDN Term
- Neural-tissue balloon catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4535 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Neural-tissue balloon catheter
NeuroBalloon™ by Integra LifeSciences Switzerland Sàrl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neural-tissue balloon catheter.
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- Matreneu® Percutaneous Balloon Compression Kit — Shenzhen Shineyard Medical Device Co. , Ltd. · Class I
- Matreneu® Percutaneous Balloon Compression Kit — Shenzhen Shineyard Medical Device Co. , Ltd. · Class I
- Matreneu® Percutaneous Balloon Compression Kit — Shenzhen Shineyard Medical Device Co. , Ltd. · Class I
- Matreneu® Percutaneous Balloon Compression Kit — Shenzhen Shineyard Medical Device Co. , Ltd. · Class I
- Matreneu® Percutaneous Balloon Compression Kit — Shenzhen Shineyard Medical Device Co. , Ltd. · Class I
- Matreneu® Percutaneous Balloon Compression Kit — Shenzhen Shineyard Medical Device Co. , Ltd. · Class I
- Matreneu® Percutaneous Balloon Compression Kit — Shenzhen Shineyard Medical Device Co. , Ltd. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Integra LifeSciences Switzerland Sàrl
Sources (1)
- FDA UDI fd885f88-fbf8-4113-a64d-7a19f2316633 37 fields · synced Jun 8, 2026