AccessGUDID - DEVICE: Needle / Guide Wire

GUDID

Device Identifier (DI) Information

Brand Name: Needle / Guide Wire - Set
Version or Model: JMSN18GW11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: JMSN18GW11
Company Name: Joimax GmbH

Primary DI Number: 04250337103929
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344267187 *Terms of Use

Device Description: joimax® Needle and Guide Wire Set

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:	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?
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
GAA	NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 18G Needle L 110 mm, Guide Wire 300 mm

Device Record Status

Public Device Record Key: f811eb5b-b0f0-45f4-b199-b89a87ba2fa6
Public Version Date: January 09, 2023
Public Version Number: 1
DI Record Publish Date: December 30, 2022