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Invotec Ultra-Stat
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 20-10700Model Epistaxis Nasal Pack
Identity
- Trade Name
- Ultra-Stat Epistaxis Nasal Balloon EUDAMEDInvotec Ultra-Stat FDA UDI
- Generic Name
- Nasal haemostatic balloon FDA UDI
- Device Name
- Epistaxis Nasal Balloon EUDAMEDUltra Stat Epistaxis Nasal Balloon, Silicone FDA UDI
- Model / Reference
- 20-10700 EUDAMEDFDA UDIEpistaxis Nasal Pack EUDAMED
- Description
- Ultra Stat Epistaxis Nasal Balloon, Silicone FDA UDI
Identifiers
- Catalog Number
- 20-10700 FDA UDI
- Primary DI / UDI-DI
- 00818501020669 EUDAMEDFDA UDI
- Basic UDI-DI
- 081850102EpistaxisPack5V EUDAMED
- FDA Product Code
- EMX FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Nasal haemostatic balloon FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4100 FDA UDI
- Market of Registration
- Austria 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
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
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
Invotec Ultra-Stat by Invotec International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Invotec International, Inc.
Sources (2)
- FDA UDI 2caf976f-3f23-4d7c-b59a-9787f16dced6 34 fields · synced Jul 26, 2026
- EUDAMED 10d3d970-3b85-4c5b-bf10-df4776f2e67f 61 fields · synced Jul 26, 2026