Identity
- Trade Name
- Sample, Lighted Placement Tool FDA UDI
- Generic Name
- Earmould impression block insertion tool FDA UDI
- Device Name
- Sample, Lighted Placement Tool FDA UDI
- Model / Reference
- SP-22850 FDA UDI
- Description
- Sample, Lighted Placement Tool FDA UDI
Identifiers
- Catalog Number
- 22850 FDA UDI
- Primary DI / UDI-DI
- 00714646001030 FDA UDI
- FDA Product Code
- JYG FDA UDI
- GMDN Term
- Earmould impression block insertion tool 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Earmould impression block insertion tool
Sample, Lighted Placement Tool by Bionix, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Earmould impression block insertion tool.
- Lighted Placement Tool — Bionix, LLC · 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
- Bionix, LLC
Sources (1)
- FDA UDI 600430a2-bdf0-431f-bc83-2f654f24ab24 35 fields · synced May 30, 2026