AccessGUDID - DEVICE: Leksell Stereotactic System (07340048301893)

GUDID

Device Identifier (DI) Information

Brand Name: Leksell Stereotactic System
Version or Model: 404888
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Elekta Instrument AB

Primary DI Number: 07340048301893
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 507772663 *Terms of Use

Device Description: FIXATION SCREW 20 MM, TITANIUM

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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

GMDN Preferred Term Name	GMDN Definition
Neurological stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

FDA Product Code

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Product Code	Product Code Name
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152558	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify:
Length: 20.0 Millimeter

Device Record Status

Public Device Record Key: 06745ea3-f7cb-4f5f-917e-36597883789f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016