Identity
- Trade Name
- FENTEX FDA UDI
- Generic Name
- Nasal speculum, reusable FDA UDI
- Device Name
- Nasal Speculum by Cottle 13 cm, size 1, blade length 35 mm FDA UDI
- Model / Reference
- 300201FX FDA UDI
- Description
- Nasal Speculum by Cottle 13 cm, size 1, blade length 35 mm FDA UDI
Identifiers
- Catalog Number
- 300201FX FDA UDI
- Primary DI / UDI-DI
- 04250407727055 FDA UDI
- FDA Product Code
- EPY FDA UDI
- GMDN Term
- Nasal speculum, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.1800 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Nasal speculum, reusable
This nasal speculum by Cottle is a high-quality, reusable device used for general ENT surgical interventions. The 13 cm device features two blunt, contoured blades that are expanded by applying pressure to the pivoted handles, allowing for maximum open access. It has been labeled as not MRI safety information and is exempt from PM exemptions.
Similar devices
Also classified as Nasal speculum, reusable.
- Cottle septum speculum — Spiggle & Theis Medizintechnik GmbH · Class I
- Integra® — Integra LifeSciences Production Corporation · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Papavero Speculum, Titanium, 90x13mm Jaw — MIZUHO AMERICA, INC. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · 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
- FENTEX medical GmbH
Sources (1)
- FDA UDI aa102216-a510-4993-bca3-17139a6f7eb5 35 fields · synced Jul 24, 2026