Identity
- Trade Name
- MOSQUITO HEMOSTAT EUDAMEDOrmco FDA UDI
- Generic Name
- Dental dressing forceps, reusable FDA UDI
- Device Name
- Tweezer EUDAMEDMOSQUITO HEMOSTAT FDA UDI
- Model / Reference
- 8**- EUDAMED801-0037 EUDAMEDFDA UDI
- Description
- MOSQUITO HEMOSTAT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989075748 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889989-HI_Tweezers-F4 EUDAMED
- FDA Product Code
- HTD FDA UDI
- EMDN Code
- L150799 ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental dressing forceps, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mosquito Hemostat by Ormco Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0889989-HI_Tweezers-F4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED 523916be-1443-4fbd-b0b5-9838910ee681 61 fields · synced Jun 17, 2026
- FDA UDI 8e0c5d28-ed17-4096-89a2-19a49edd5d43 34 fields · synced May 30, 2026