DEVICE: Reference Interconnector Iop Imaging (04056481004613)

Device Identifier (DI) Information

Reference Interconnector Iop Imaging
19145-02
In Commercial Distribution
19145-02
Brainlab AG
04056481004613
GS1

1
314482980 *Terms of Use
No description.
CLOSE

Device Characteristics

MR Conditional
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Robotic surgical navigation system An assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HAW Neurological Stereotaxic Instrument
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092467 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

0c170ca7-2fe4-4e78-be1e-879921e15659
July 06, 2018
3
September 15, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+49899915680
contact@brainlab.com
CLOSE