Identity
- Trade Name
- Hopkins Medical Products® FDA UDI
- Generic Name
- Ear speculum, single-use FDA UDI
- Device Name
- Welch Allyn KleenSpec 4.25mm Disposable Ear Specula PK850 FDA UDI
- Model / Reference
- 542434 FDA UDI
- Description
- Welch Allyn KleenSpec 4.25mm Disposable Ear Specula PK850 FDA UDI
Identifiers
- Catalog Number
- 542434 FDA UDI
- Primary DI / UDI-DI
- 00817643021831 FDA UDI
- FDA Product Code
- HIB FDA UDI
- GMDN Term
- Ear speculum, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ear speculum, single-use
Hopkins Medical Products® by Hopkins Uniform Company — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Hopkins Uniform Company
Sources (1)
- FDA UDI 3835d102-3d78-4154-9ff9-1d296b01d392 35 fields · synced May 30, 2026