AccessGUDID - DEVICE: Spinal Jaxx Interbody Fusion Device (00818956020702)

GUDID

Device Identifier (DI) Information

Brand Name: Spinal Jaxx Interbody Fusion Device
Version or Model: 100001-382
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100001-382
Company Name: NEUROPRO SPINAL JAXX INC.

Primary DI Number: 00818956020702
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080554344 *Terms of Use

Device Description: 25 mm Implant Height Indicator

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?
47863	Surgical instrument/implant depth limiter, reusable	A device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to prevent insertion below the surgical field of interest thereby avoiding damage to tissue behind or below target structures. It is typically made of high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152501	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 25 Millimeter

Device Record Status

Public Device Record Key: 171f33fc-1821-4a0f-9b9d-467614103d64
Public Version Date: November 07, 2024
Public Version Number: 6
DI Record Publish Date: March 24, 2017