Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Laryngeal knife FDA UDI
- Device Name
- Kleinsasser laryngeal needle, curved right FDA UDI
- Model / Reference
- Kleinsasser laryngeal needle FDA UDI
- Description
- Kleinsasser laryngeal needle, curved right FDA UDI
Identifiers
- Catalog Number
- 57-235 FDA UDI
- Primary DI / UDI-DI
- 00190660121419 FDA UDI
- FDA Product Code
- KBR FDA UDI
- GMDN Term
- Laryngeal knife 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Laryngeal knife
Ambler Surgical by Ambler Surgical, LLC — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 4f57dd72-21d3-4e55-9383-0369b9819fb1 35 fields · synced Jun 7, 2026