Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Nasal file/rasp FDA UDI
Device Name: Maltz nasal rasp, 6 5/8'', straight, backward cutting, grit 2, 7.5mm wide, TC teeth, flat handle FDA UDI
Model / Reference: Maltz nasal rasp FDA UDI
Description: Maltz nasal rasp, 6 5/8'', straight, backward cutting, grit 2, 7.5mm wide, TC teeth, flat handle FDA UDI

Identifiers

Catalog Number: 69-542 FDA UDI
Primary DI / UDI-DI: 00190660129965 FDA UDI
FDA Product Code: KBA FDA UDI
GMDN Term: Nasal file/rasp 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

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: Nasal file/rasp

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

Similar devices

Also classified as Nasal file/rasp.

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Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Parkes nasal rasp — Spiggle & Theis Medizintechnik GmbH · Class I
HNM MEDICAL — HNM STAINLESS, LLC. · Class I
MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH · Class I
PILLING — TELEFLEX INCORPORATED · 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 311d1d58-6b97-4e82-961e-9079bcb6122a 35 fields · synced Jun 8, 2026