AccessGUDID - DEVICE: Rampart T Lumbar Interbody Fusion Device (M7403663511)

GUDID

Device Identifier (DI) Information

Brand Name: Rampart T Lumbar Interbody Fusion Device
Version or Model: 10-10-72-15
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 366-3511
Company Name: SPINEOLOGY INC.

Primary DI Number: M7403663511
Issuing Agency: HIBCC
Commercial Distribution End Date: May 04, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: Spinal Implant

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?
61609	Vertebral body bone graft pouch	A sterile, implantable, mesh bag designed to contain and maintain the position of bone graft materials that have been implanted into a vertebral body defect, following bone tissue removal, to treat defects typically caused by trauma, deformity, tumours, or degenerative diseases. It is made of woven/knitted non-bioabsorbable synthetic polymer(s) material. Dedicated disposable devices associated with implantation may be included.	Active	true

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 [?]
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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 11 Millimeter
Device Size Text, specify: 11x35

Device Record Status

Public Device Record Key: 7b54b6c2-65e2-4273-a575-f1ebb0069f62
Public Version Date: May 05, 2021
Public Version Number: 4
DI Record Publish Date: November 28, 2016