AccessGUDID - DEVICE: SPINEMASK (37613252731437)

GUDID

Device Identifier (DI) Information

Brand Name: SPINEMASK
Version or Model: 6002-390-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6002-390-000
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 37613252731437
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: SPINEMASK (TM) TRACKER

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?
62782	Optical surgical navigation device tracking system	A mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)]; it may be capable of creating digital 3-D patient models. It consists of a workstation with controls/display, position/movement tracking cameras (e.g., infrared), adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ENT, neurosurgery, CMF surgery].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLO	Orthopedic 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 Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: TRANSPORT -20 DEGREES CELSIUS TO 70 DEGREES CELSIUS
Special Storage Condition, Specify: TRANSPORT 10-90 PERCENT HUMIDITY
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 4 and 35 Degrees Celsius
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Special Storage Condition, Specify: 50-106KPA

Clinically Relevant Size

[?]

Size Type Text
Height: 25.0 Millimeter
Width: 255.0 Millimeter
Length: 377.0 Millimeter

Device Record Status

Public Device Record Key: fe333605-6c58-40f7-9fe4-44889025f238
Public Version Date: April 04, 2025
Public Version Number: 7
DI Record Publish Date: September 21, 2016