FDA.reportPublic FDA data

DRAPELINK REF ADAPTER AUTO-REG IMRI

Primary DI
04056481145392
Brand
DRAPELINK REF ADAPTER AUTO-REG IMRI
Company
Brainlab SE
Model
19208-02A
Published
2023-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092467000
K223288000
K223864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092467000VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITEDBrainlab AG2010-05-06HAW
K223288000Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRIBrainlab AG2023-07-21HAW
K223864000Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software CranialBrainlab AG2023-09-09HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481145392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481145392040564811453924056481145392

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic/optical surgical navigation/tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures, commonly with respect to pre-acquired images and/or real-time data [e.g., computed tomography (CT), ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].

Regulatory Flags#

DUNS number
314482980
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481147969Spine and Trauma Navigation3.12026-10-19
04056481145200DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)549292023-10-17
04056481146702Curve Navigation177022025-10-13
04056481146054Patient Reference Rod-Clamp Spine & Trauma558262025-09-19
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S558242025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L558252025-06-17
04056481144906Spine &Trauma Navigation3.02024-11-14
04056481146238PATIENT REFERENCE ARRAY SPINE & TRAUMA55761B2024-11-14
04056481146603ADAPTER SHORT FOR PATIENT REFERENCE CLAMP55761-01B2024-11-14
04056481146610ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY52419A2024-11-14
04056481144753Drill Guide Array51839-032024-06-04
04056481144760Drill Guide Depth Control (60 - 100 mm)51839-022024-06-04
04056481144777Drill Guide Depth Control (0 - 60 mm)51839-012024-06-04
04056481144784Drill Guide Tube (4.5 mm)51839-452024-06-04
04056481144791Drill Guide Tube (3.2 mm)51839-322024-06-04
04056481144807Drill Guide Tube (2.6 mm)51839-262024-06-04
04056481144814Drill Guide Tube (2.4 mm)51839-242024-06-04
04056481144821Drill Guide Tube (2.0 mm)51839-202024-06-04
04056481144838Drill Guide Handle518392024-06-04
04056481145057Drill Guide Trocar Insert (2.0 mm)51839-932024-06-04

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