AccessGUDID - DEVICE: Optiport, 11.5mm I.D. (81195401213724)

GUDID

Device Identifier (DI) Information

Brand Name: Optiport, 11.5mm I.D.
Version or Model: 6173-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6173-00
Company Name: INTERVENTIONAL SPINE, INC

Primary DI Number: 81195401213724
Issuing Agency: GS1
Commercial Distribution End Date: December 23, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 017663522 *Terms of Use

Device Description: PerX360 System, Optiport

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?
37890	Lumbar decompression procedure kit	A collection of sterile devices used to perform percutaneous, minimally-invasive lumbar decompression (MILD) for the treatment of various spine conditions, typically in conjunction with an endoscope. It typically includes trocars, cannulae (portals), a retractor, and other essential materials for the procedure; it may also include a disposable endoscope. It is used for image-guided tissue resection of the lumbar spine involving retraction, grasping, cutting, ablation, and coagulation of the spinal tissues. This is a single-use 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: 6b9f6e1c-5caf-4673-89ba-fed6af2a175b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2015