Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- General-purpose curette FDA UDI
- Device Name
- Long neck curette, 15'', angled 30 degrees, size #1 cup, hollow lightweight round handle FDA UDI
- Model / Reference
- Long neck curette FDA UDI
- Description
- Long neck curette, 15'', angled 30 degrees, size #1 cup, hollow lightweight round handle FDA UDI
Identifiers
- Catalog Number
- 19-554 FDA UDI
- Primary DI / UDI-DI
- 00190660023317 FDA UDI
- FDA Product Code
- HAO FDA UDI
- GMDN Term
- General-purpose curette FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4535 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: General-purpose curette
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose curette.
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Dermal Curette — SONTEC INSTRUMENTS, INC. · Class I
- Curette — Koros USA, Inc. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Impulse Interbody Spacer System — Degen Medical · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Curette — Koros USA, 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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 7db0b6a7-1eb8-4906-862a-e38c053a45fb 35 fields · synced May 30, 2026