AccessGUDID - DEVICE: Lumbar Interbody Fusion System (OLLIF) (00850014575540)

GUDID

Device Identifier (DI) Information

Brand Name: Lumbar Interbody Fusion System (OLLIF)
Version or Model: 01-9080-18T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-9080-18T
Company Name: ADVANCED RESEARCH MEDICAL LLC

Primary DI Number: 00850014575540
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117201206 *Terms of Use

Device Description: Lumbar Interbody Fusion System (OLLIF) Guide Wire - 1.4 mm X 18 in [Threaded]

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
63819	Spinal guidewire	A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.	Active	false

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 [?]
K173947	000

Device Exempt from Premarket Submission: No 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
Guidewire Diameter: 1.4 Millimeter
Length: 18 Inch

Device Record Status

Public Device Record Key: a61ba35b-ad96-4b00-9c65-4cdbb58aeb8b
Public Version Date: March 12, 2024
Public Version Number: 3
DI Record Publish Date: February 03, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
10850014575547	10	00850014575540	In Commercial Distribution
20850014575544	25	00850014575540	In Commercial Distribution
30850014575541	100	00850014575540	In Commercial Distribution