FDA.reportPublic FDA data

Disposable Pre-calibrated Suction Charr. 12

Primary DI
04056481141134
Brand
Disposable Pre-calibrated Suction Charr. 12
Company
Brainlab AG
Model
52185-01
Device description
Disposable suction 4mm
Published
2021-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

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
K201752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201752000Disposable Pre-calibrated SuctionBrainlab AG2021-01-29HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481141134PackageGS110In Commercial Distribution
04056481141141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481141134040564811411344056481141134
04056481141141040564811411414056481141141

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking system suction cannulaAn atraumatic, invasive, hand-operated, rigid/semi-rigid tubular component of an optical surgical navigation device tracking system designed as a conduit for aspiration of body cavities or surgical sites to facilitate observation and/or to clear airway obstruction, typically during a cranial and/or ENT procedure, in association with computer assisted surgery (CAS); it is not intended for surgical irrigation. Also referred to as a suction tube or tip, it incorporates a handle with features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera [e.g., infrared (IR) light camera]; it does not include a light source or fibreoptic bundle. This is a single-use device.

Sterilization Methods#

Method table
Method

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
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
04056481145941Disposable Loop-X Source Drape (1 Pc)22183-122025-07-25
04056481145934Disposable Loop-X Detector Drape (1 Pc)22183-132025-07-24
04056481141677Cirq Robotic Disposable Kinematic Unit56102-01 2022-12-23
04056481145224DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE S) (3 PCS))41860- 442024-05-22
04056481145231DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE M) (3 PCS)41860-45 2024-05-22
04056481145248DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE L) (3 PCS)41860- 462024-05-22
04056481145217DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)549292023-10-17
04056481142827Loop-X Disposable Sterile Drape Set22183-012021-10-12
04056481004958Em Disposable Stylet18097180972018-02-08

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Primary DI, Brand, Company table
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07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
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