Identity
- Trade Name
- ADEPT MEDICAL FDA UDI
- Generic Name
- Middle ear pick FDA UDI
- Device Name
- ROSEN INSERTERS DISPOSABLE PK/100 FDA UDI
- Model / Reference
- 38-1440 FDA UDI
- Description
- ROSEN INSERTERS DISPOSABLE PK/100 FDA UDI
Identifiers
- Catalog Number
- 38-1440 FDA UDI
- Primary DI / UDI-DI
- M6333814401 FDA UDI
- FDA Product Code
- JYT FDA UDI
- GMDN Term
- Middle ear pick 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Middle ear pick
Adept Medical by JEDMED Instrument Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Novo Surgical — NOVO SURGICAL, 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
- JEDMED Instrument Company
Sources (1)
- FDA UDI e0403924-5091-4b85-ad34-5089be676345 34 fields · synced Jun 8, 2026