AccessGUDID - DEVICE: N/A (07613327499711)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 8900-200-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8900-200-200
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613327499711
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: EM Stylet

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63570	Intracranial catheter navigation transmitter stylet	A sterile, invasive, flexible wire with an electromagnetic (EM) coil transmitter at the distal end designed to be inserted into an intracranial catheter to help guide the surgical insertion of the catheter through the skull for placement in the brain. It is proximally connected to a line-powered EM neurosurgical navigation system which tracks and displays the position of the stylet for precise navigation during the procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Special Storage Condition, Specify: Fragile, Handle with Care
Special Storage Condition, Specify: Transport humidity, 90, 10, Relative Humidity
Special Storage Condition, Specify: Transport temperature, 50, -10, Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 4 and 35 Degrees Celsius
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: Transport atmospheric pressure, 106, 70, Kilo Pascal
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 82a11bb5-4b2e-4fcf-9865-cd2803176e80
Public Version Date: March 31, 2023
Public Version Number: 1
DI Record Publish Date: March 23, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
37613327499712	5	07613327499711		In Commercial Distribution	pack

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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