AccessGUDID - DEVICE: MAGEC® Spinal Bracing and Distraction System (00856719002183)

GUDID

Device Identifier (DI) Information

Brand Name: MAGEC® Spinal Bracing and Distraction System
Version or Model: RA002-4545SL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PA0237
Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Primary DI Number: 00856719002183
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837845234 *Terms of Use

Device Description: Spinal bracing and distraction system, 4.5 mm standard rod with 90 mm actuator

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
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
PGN	Growing Rod System- Magnetic Actuation

FDA Premarket Submission

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

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
Outer Diameter: 4.5 Millimeter

Device Record Status

Public Device Record Key: d4a1cc88-eec0-4e29-8680-feb404a01c48
Public Version Date: April 25, 2018
Public Version Number: 3
DI Record Publish Date: January 15, 2016