FDA.reportPublic FDA data

CRANIAL 4PI BASIC MASK (1 PC.)

Primary DI
04056481144944
Brand
CRANIAL 4PI BASIC MASK (1 PC.)
Company
Brainlab SE
Model
43451-01
Published
2024-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202050000Cranial 4Pi ImmobilizationBrainlab AG2020-08-19IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481144944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481144944040564811449444056481144944

GMDN Terms#

Term, Definition table
TermDefinition
Indexed-immobilization patient positioning systemA assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314482980
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481145804Brainlab Origin OR1.02026-08-21
04056481006525Em Disposable Stylet18097180972018-02-08
04056481141141Disposable Pre-calibrated Suction Charr. 1252185-012021-03-08
04056481145200DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)549292023-10-17
04056481146702Curve Navigation177022025-10-13
04056481146429Automatic Regsitration2.72026-02-20
04056481146054Patient Reference Rod-Clamp Spine & Trauma558262025-09-19
04056481145613Vascular Navigation PAD2.02025-09-11
04056481146672Mixed Reality Spine Navigation1.12025-07-31
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S558242025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L558252025-06-17
04056481146320Alignment Software Spine2.12025-06-16
04056481145828Microscope Navigation1.72025-06-11
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481145620Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm564162025-02-24
04056481145637Alignment Guide Tube Cranial 4.9 mm / 8.0 mm564172025-02-24
04056481145903Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm564182025-02-24
04056481146047Cirq Robotic Tracking Array 10.056302A2025-02-24
04056481146337Alignment Software Cranial with LITT2.12025-02-24
04056481145514Z-touch Laser Registration Pointer18370-10A2025-02-13

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Primary DI, Brand, Company table
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