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Hallu®-Fix

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name
HALLU®-FIX FDA UDI
Generic Name
Fluted surgical drill bit, single-use FDA UDI
Device Name
Drill dia. 1.9mm FDA UDI
Model / Reference
119618ND FDA UDI
Description
Drill dia. 1.9mm FDA UDI

Identifiers

Catalog Number
119618ND FDA UDI
Primary DI / UDI-DI
10381780045342 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
Fluted surgical drill bit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, single-use

Hallu®-Fix by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluted surgical drill bit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Newdeal Sas

Sources (1)

  • FDA UDI 1c78f44f-481b-4936-aad9-3f3a16778628 37 fields · synced May 30, 2026