Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Rigid optical laryngopharyngoscope FDA UDI
- Device Name
- Low-Profile Dedo-Style Laser Laryngoscope, Adult is supplied with a single light carrier, flush with the handle, which accommodates a slim and lightweight blue Pilling fiberoptic cable (sold separately). Size Adult. Length 178mm, Min I.D. 10.7mm, Nominal Proximal Dims 19.0mm x 19.0mm, Max O.D. 25.5mm, FDA UDI
- Model / Reference
- 40-2221 FDA UDI
- Description
- Low-Profile Dedo-Style Laser Laryngoscope, Adult is supplied with a single light carrier, flush with the handle, which accommodates a slim and lightweight blue Pilling fiberoptic cable (sold separately). Size Adult. Length 178mm, Min I.D. 10.7mm, Nominal Proximal Dims 19.0mm x 19.0mm, Max O.D. 25.5mm, FDA UDI
Identifiers
- Catalog Number
- 40-2221 FDA UDI
- Primary DI / UDI-DI
- 00842180151901 FDA UDI
- FDA Product Code
- CCW FDA UDI
- GMDN Term
- Rigid optical laryngopharyngoscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5540 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: Rigid optical laryngopharyngoscope
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical laryngopharyngoscope.
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- PILLING — TELEFLEX INCORPORATED · Class I
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- King Vision Video Laryngoscope — KING SYSTEMS CORPORATION. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- GlideScope® — Verathon Medical (Canada) ULC · Class I
- GlideScope® — Verathon Medical (Canada) ULC · 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
- Elmed Incorporated
Sources (1)
- FDA UDI 4a2d1a1a-6db0-41fd-9e0a-02b8b810609f 35 fields · synced May 31, 2026