Identity
- Trade Name
- Formby Cerumen Hook & Probe, 178mm FDA UDI
- Generic Name
- Abdominal/ENT/orthopaedic surgical probe, single-use FDA UDI
- Model / Reference
- FCH5001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060411986916 FDA UDI
- FDA Product Code
- JYH FDA UDI
- GMDN Term
- Abdominal/ENT/orthopaedic surgical probe, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Abdominal/ENT/orthopaedic surgical probe, single-use
Formby Cerumen Hook & Probe, 178mm by Dtr Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Abdominal/ENT/orthopaedic surgical probe, single-use.
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- OSSEOUS Cerumen hook — EON MEDITECH PRIVATE LIMITED · 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
- Dtr Medical Limited
Sources (1)
- FDA UDI bf2f3e3b-a3d8-43dd-8de4-b7c11f744266 32 fields · synced Jun 1, 2026