AccessGUDID - DEVICE: n/a (07613327413113)

GUDID

Device Identifier (DI) Information

Brand Name: n/a
Version or Model: 8000-060-030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8000-060-030
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613327413113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: Instrument Clip Electromagnetic 4mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
58183	Electromagnetic surgical navigation device tracking system	An assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PGW	Ear, Nose, and Throat 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
Special Storage Condition, Specify: Keep Dry
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Special Storage Condition, Specify: Keep away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c33610db-71da-4165-8b07-7b60d4c97d8a
Public Version Date: September 18, 2023
Public Version Number: 3
DI Record Publish Date: October 12, 2018