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Epistax Balloon Catheter
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref RH-4400-10Ref RH-4420-01
Identity
- Trade Name
- Epistax Balloon Catheter EUDAMEDFDA UDI
- Generic Name
- Nasal haemostatic balloon FDA UDI
- Device Name
- Epistax Balloon Catheter EUDAMED
- Model / Reference
- RH-4420-01 EUDAMEDFDA UDIRH-4400-10 EUDAMEDFDA UDIRH-4200-10 FDA UDI
Identifiers
- Catalog Number
- RH-4200-10 FDA UDIRH-4420-01 FDA UDIRH-4400-10 FDA UDI
- Primary DI / UDI-DI
- 00385640000369 EUDAMEDFDA UDI00385640000352 EUDAMEDFDA UDI00385640000321 FDA UDI
- Basic UDI-DI
- 03856490305_EPISTAXI8S EUDAMED
- FDA Product Code
- EMX FDA UDI
- EMDN Code
- Q030201 EPISTAXIS CATHETERS EUDAMED
- GMDN Term
- Nasal haemostatic balloon FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4100 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nasal haemostatic balloon
Epistax Balloon Catheter by Summit Medical, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nasal haemostatic balloon.
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- Rapid Rhino — Smith & Nephew, Inc. · Class I
- Epi-Max™ Epistaxis Catheter — Boston Medical Products, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Summit Medical, LLC
Sources (5)
- FDA UDI 4dc51db8-e165-4453-94b8-3324ae70233d 34 fields · synced Jul 10, 2026
- FDA UDI ff2cd86a-50c5-4cb7-9ecb-a4340bdf0e50 34 fields · synced May 30, 2026
- FDA UDI d145f712-ca48-43f1-9d78-cf906406d9af 34 fields · synced May 30, 2026
- EUDAMED 44f05749-ccbc-4592-831a-2875feeab40e 61 fields · synced Jul 10, 2026
- EUDAMED 50d6ad99-2c8b-45c3-aa9c-7ebe51288f18 61 fields · synced Jul 10, 2026