AccessGUDID - DEVICE: JAZZ System (03607503506878)

GUDID

Device Identifier (DI) Information

Brand Name: JAZZ System
Version or Model: Jazz Rod - Straight Union Rod Dia.6.0 L300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 350687
Company Name: IMPLANET

Primary DI Number: 03607503506878
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 291993439 *Terms of Use

Device Description: No description.

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):	No
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?
37272	Trans-facet-screw internal spinal fixation system, sterile	A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System
OWI	Bone Fixation Cerclage, Sublaminar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182771	000
K191217	000

Device Exempt from Premarket Submission: No 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
Lumen/Inner Diameter: 6 Millimeter
Length: 300 Millimeter

Device Record Status

Public Device Record Key: 7608a9d0-d191-4a28-9c0e-29c3a6b4743b
Public Version Date: September 26, 2019
Public Version Number: 2
DI Record Publish Date: March 20, 2019