Bl Impactor Universal Nose Conical 15Mm 52855-64

GUDID 04056481001971

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481001971
NIH Device Record Keyb618f9c0-2a3b-464b-89c9-3fad9a92fe79
Commercial Distribution StatusIn Commercial Distribution
Brand NameBl Impactor Universal Nose Conical 15Mm
Version Model Number52855-64
Catalog Number52855-64
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481001971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481001971]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

Devices Manufactured by Brainlab AG

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04056481141677 - Cirq Robotic Disposable Kinematic Unit2025-03-26
04056481125967 - Patient Mask Set 2025-03-18
04056481142698 - Frameless SRS MASK SET CRANIAL2025-03-18
04056481142704 - Frameless SRS MASK SET EXTENDED 2025-03-18
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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