Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- ENT surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Penfield #4 Push/Pull, Bayoneted, Dual Sided, 8-5/8” Overall Length, 1/2” Bayonet (bend to bend), .062 Hole on each end in handle, Ebonized black finish FDA UDI
- Model / Reference
- ST389649 FDA UDI
- Description
- Penfield #4 Push/Pull, Bayoneted, Dual Sided, 8-5/8” Overall Length, 1/2” Bayonet (bend to bend), .062 Hole on each end in handle, Ebonized black finish FDA UDI
Identifiers
- Catalog Number
- ST389649 FDA UDI
- Primary DI / UDI-DI
- 00198506006777 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- ENT surgical procedure kit, non-medicated, reusable 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: ENT surgical procedure kit, non-medicated, reusable
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Elmed Incorporated
Sources (1)
- FDA UDI a8957152-7a92-4247-be4f-dd73b737f20f 35 fields · synced Jun 8, 2026