Cirq Robotic Disposable Kinematic Unit

Primary DI
04056481141677
Brand
Cirq Robotic Disposable Kinematic Unit
Company
Brainlab AG
Model
56102-01
Published
2022-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202320000CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine SystemBrainlab AG2020-12-23OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481141677PackageGS15In Commercial Distribution
04056481144319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481141677040564811416774056481141677
04056481144319040564811443194056481144319

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, power-adjustedA device assembly adjusted or stabilized by electrical, electro-pneumatic or pneumatic means, intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

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
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
04056481145941Disposable Loop-X Source Drape (1 Pc)22183-122025-07-25
04056481145934Disposable Loop-X Detector Drape (1 Pc)22183-132025-07-24
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
04056481141134Disposable Pre-calibrated Suction Charr. 1252185-012021-03-08
04056481004958Em Disposable Stylet18097180972018-02-08

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Primary DI, Brand, Company table
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