Identity
- Trade Name
- Killian Nasal Speculum 75mm/13cm FDA UDI
- Generic Name
- Nasal speculum, reusable FDA UDI
- Device Name
- A hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device. FDA UDI
- Model / Reference
- 10-034-03 FDA UDI
- Description
- A hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- 10-034-03 FDA UDI
- Primary DI / UDI-DI
- G25010034030 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
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
Dimensions & Sizes
- Size
- Length — 13 Centimeter FDA UDI
Category: Nasal speculum, reusable
Killian Nasal Speculum 75mm/13cm by N S Surgical Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal speculum, reusable.
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- Integra® — Integra LifeSciences Production Corporation · Class I
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- FENTEX — FENTEX medical 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
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
- N S Surgical Company
Sources (1)
- FDA UDI e6270771-363d-4b15-8275-e403816a4e70 35 fields · synced Jun 1, 2026