Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: General-purpose curette FDA UDI
Device Name: Hardy transsphenoidal curette, 9 1/2'', bayonet shaft, working length 120mm, angled 45 degrees down 3.0mm cup, round handle FDA UDI
Model / Reference: Hardy transsphenoidal curette FDA UDI
Description: Hardy transsphenoidal curette, 9 1/2'', bayonet shaft, working length 120mm, angled 45 degrees down 3.0mm cup, round handle FDA UDI

Identifiers

Catalog Number: 19-522 FDA UDI
Primary DI / UDI-DI: 00190660022129 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

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 4938f862-5cc2-439b-9447-6c1734e87666 35 fields · synced May 30, 2026