AccessGUDID - DEVICE: Rampart-O (M7402803011)

GUDID

Device Identifier (DI) Information

Brand Name: Rampart-O
Version or Model: 83-02-10-11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 280-3011
Company Name: SPINEOLOGY INC.

Primary DI Number: M7402803011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: 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: No
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
Device Size Text, specify: 11x30
Length: 11 Millimeter

Device Record Status

Public Device Record Key: e38e39f4-6de2-4916-b17d-380b2f88fd56
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 05, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(612)256-8500 ext: 534
Email: jhauge@spineology.com

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