AccessGUDID - DEVICE: Rampart-O (M9403802511)

GUDID

Device Identifier (DI) Information

Brand Name: Rampart-O
Version or Model: 10-10-41-5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 380-2511
Company Name: SPINEOLOGY INC.

Primary DI Number: M9403802511
Issuing Agency: HIBCC
Commercial Distribution End Date: September 18, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: Asm, Rampart-O

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: 11x25

Device Record Status

Public Device Record Key: d188eb3b-083c-49e7-95f7-feda2aa79b1d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 04, 2015