AccessGUDID - DEVICE: N/A (07613327500578)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 8000-050-009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8000-050-009
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613327500578
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: Registration Pointer

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:	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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45169	Stereotactic surgery system probe, reusable	A slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLO	Orthopedic stereotaxic instrument
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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 98ba81b8-6a80-4b14-8b4a-0b3eec8e926e
Public Version Date: February 14, 2025
Public Version Number: 5
DI Record Publish Date: July 22, 2022

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

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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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