Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Bronchial cannula FDA UDI
Device Name: Injection cannula for use with Kleinsasser operating laryngoscopes FDA UDI
Model / Reference: Injection cannula for use with Kleinsasser operating laryngoscopes FDA UDI
Description: Injection cannula for use with Kleinsasser operating laryngoscopes FDA UDI

Identifiers

Catalog Number: 15-090 FDA UDI
Primary DI / UDI-DI: 00190660004972 FDA UDI
FDA Product Code: KCE FDA UDI
GMDN Term: Bronchial cannula FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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: Bronchial cannula

Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bronchial cannula.

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Insighters — Shenzhen Insighters Medical Technology Co., Ltd. · 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 b7127862-64a1-4ec1-b272-5155e4a4c5f9 35 fields · synced Jun 8, 2026