Identity
- Trade Name
- SINUS CURETTE B-5 HD FDA UDI
- Generic Name
- Paranasal sinus curette FDA UDI
- Model / Reference
- 10-5118HD FDA UDI
Identifiers
- Primary DI / UDI-DI
- D928105118HD0 FDA UDI
- FDA Product Code
- EKE FDA UDI
- GMDN Term
- Paranasal sinus curette FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Paranasal sinus curette
A comprehensive medical device directory featuring the Sinus Curette B-5 HD, a reusable sinus curette designed for scraping and excising tissue from paranasal sinuses.
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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
- W.H. Holden, Inc.
Sources (1)
- FDA UDI 64a6647a-f8b2-40e8-9832-9e2daddf02fe 32 fields · synced Jul 30, 2026