AccessGUDID - DEVICE: Medtronic Reusable Instruments (00763000168704)

GUDID

Device Identifier (DI) Information

Brand Name: Medtronic Reusable Instruments
Version or Model: EX0318090
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00763000168704
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: DILATOR EX0318090 ONE STEP INNER

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?
32579	Spinal endoscopic-access system	An assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic manual surgical instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 46fcdc24-53c0-4762-b15c-bb20ead12ceb
Public Version Date: October 11, 2022
Public Version Number: 1
DI Record Publish Date: October 03, 2022