Drill Guide Tube (2.0 mm)

GUDID 04056481144821

Brainlab AG

Surgical drill guide, reusable
Primary Device ID04056481144821
NIH Device Record Keye0bfbaab-8693-41a4-b635-59ac5dde021b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrill Guide Tube (2.0 mm)
Version Model Number51839-20
Company DUNS314482980
Company NameBrainlab AG
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481144821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


[04056481144821]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-12
Device Publish Date2024-06-04

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04056481145620 - Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm2025-03-04
04056481145637 - Alignment Guide Tube Cranial 4.9 mm / 8.0 mm2025-03-04
04056481145903 - Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm2025-03-04

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