Identity
- Trade Name
- Rosen round knife FDA UDI
- Generic Name
- Ear knife FDA UDI
- Device Name
- 45° 2.0 mm, 16 cm FDA UDI
- Model / Reference
- 10-610-20 FDA UDI
- Description
- 45° 2.0 mm, 16 cm FDA UDI
Identifiers
- Catalog Number
- 10-610-20 FDA UDI
- Primary DI / UDI-DI
- 04250381849224 FDA UDI
- FDA Product Code
- KTG FDA UDI
- GMDN Term
- Ear knife FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ear knife
Rosen round knife by Spiggle & Theis Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ear knife.
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- BOSS Instruments — Boss Instruments, Ltd. · Class I
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- BOSS Instruments — Boss Instruments, Ltd. · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- FENTEX — FENTEX medical GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · 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
- Spiggle & Theis Medizintechnik GmbH
Sources (1)
- FDA UDI c964c7e8-3719-4df7-9a9d-468e918ae06c 35 fields · synced May 29, 2026