AccessGUDID - DEVICE: Rampart One Lumbar Interbody Fusion System (M7404900016)

GUDID

Device Identifier (DI) Information

Brand Name: Rampart One Lumbar Interbody Fusion System
Version or Model: 49-02-05
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 490-0016
Company Name: SPINEOLOGY INC.

Primary DI Number: M7404900016
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: Rampart One Tray 1 of 2 Base Sterilization Tray

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:	No
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?
12143	Instrument tray, reusable	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32fef263-1f86-4c17-9049-7ccc10969143
Public Version Date: January 17, 2024
Public Version Number: 1
DI Record Publish Date: January 09, 2024