Surgify Halo | 5.4 mm | Short

GUDID 06429811532090

Surgify Medical Oy

Orthopaedic bur, single-use
Primary Device ID06429811532090
NIH Device Record Key50337fd7-6dbf-4ab1-9252-25524310f4c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgify Halo | 5.4 mm | Short
Version Model Number54.070.NVG.H1
Company DUNS368510617
Company NameSurgify Medical Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106429811532090 [Primary]

FDA Product Code

HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-10
Device Publish Date2025-04-02

Devices Manufactured by Surgify Medical Oy

06429811532069 - Surgify Halo | 4.0 mm | Short2025-06-26
06429811532076 - Surgify Halo | 4.0 mm | Extendable2025-06-26
06429811532083 - Surgify Halo | 4.0 mm | Long2025-06-26
06429811532090 - Surgify Halo | 5.4 mm | Short2025-04-10
06429811532090 - Surgify Halo | 5.4 mm | Short2025-04-10
06429811532106 - Surgify Halo | 5.4 mm | Long2025-04-10
06429811532120 - Surgify Halo | 5.4 mm | Medium2025-04-10
06429811532137 - Surgify Halo | 5.4 mm | Long2025-04-10
06429830116998 - Surgify Halo | 5.4 mm | Extendable2025-04-10

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