AccessGUDID - DEVICE: 4CIS® Marlin ACIF Cage SYSTEM (08806373583285)

GUDID

Device Identifier (DI) Information

Brand Name: 4CIS® Marlin ACIF Cage SYSTEM
Version or Model: 5901-0145
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5901-0145
Company Name: ALPHANOX CO.,LTD.

Primary DI Number: 08806373583285
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687844241 *Terms of Use

Device Description: 4CIS® Marlin Trial 14x12, H5

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:	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?
60725	Transfemoral amputation tissue-reinforcement implant trial	A copy of a final transfemoral amputation tissue-reinforcement implant intended to be used during orthopaedic surgery to accurately size a transfemoral amputation tissue-reinforcement implant (medullary canal rod and bulb) prior to implantation, following a transfemoral (above-the-knee) amputation. It is typically made of metal or polymer materials and includes trial rods and/or trial bulbs; it is typically available in a set of trial implants of graduated sizes. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162402	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
No Device Sizes

Device Record Status

Public Device Record Key: 92c540ab-8f6d-48c9-b4ac-833274c528fa
Public Version Date: October 29, 2024
Public Version Number: 4
DI Record Publish Date: November 12, 2018