gSource

FDA UDI

Class I (US FDA UDI)

by Gsource, Llc.

Identity

Trade Name: gSource FDA UDI
Generic Name: Nasal file/rasp FDA UDI
Device Name: Maltz Rasp DE 8 1/2" 8mm str upcutting and downcutting serr FDA UDI
Model / Reference: gS 62.1670 FDA UDI
Description: Maltz Rasp DE 8 1/2" 8mm str upcutting and downcutting serr FDA UDI

Identifiers

Catalog Number: gS 62.1670 FDA UDI
Primary DI / UDI-DI: 00840314232496 FDA UDI
FDA Product Code: HTR FDA UDI
GMDN Term: Nasal file/rasp 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

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

gSource by Gsource, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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HNM MEDICAL — HNM STAINLESS, LLC. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · 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: Gsource, Llc.

Sources (1)

FDA UDI 801fc635-e306-4f6b-9ddb-d505f7543515 34 fields · synced Jun 8, 2026