Identity
- Trade Name
- ADC® FDA UDI
- Generic Name
- Ear speculum, single-use FDA UDI
- Device Name
- Specula, Reusable for 5211,Size 4.5mm FDA UDI
- Model / Reference
- 5211-3 FDA UDI
- Description
- Specula, Reusable for 5211,Size 4.5mm FDA UDI
Identifiers
- Catalog Number
- 5211-3 FDA UDI
- Primary DI / UDI-DI
- 00634782040352 FDA UDI
- FDA Product Code
- EPY FDA UDI
- GMDN Term
- Ear speculum, single-use 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
Yes
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
Dimensions & Sizes
- Size
- Length — 4.5 Millimeter FDA UDI
Category: Ear speculum, single-use
Adc® by American Diagnostic Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ear speculum, single-use.
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- JEDMED — JEDMED Instrument Company · Class I
- OtoSight Speculum Tip Combination Package — Photonicare, Inc. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
- CFM Technologies — C F M TECHNOLOGIES INC · Class I
- CFM Technologies — C F M TECHNOLOGIES INC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · 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
- American Diagnostic Corporation
Sources (1)
- FDA UDI 63a7d1af-e01d-421a-8417-134bc56a3fee 36 fields · synced May 31, 2026