AccessGUDID - DEVICE: AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 100mm (00848665021189)

GUDID

Device Identifier (DI) Information

Brand Name: AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 100mm
Version or Model: 1300-100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Primary DI Number: 00848665021189
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 117858154 *Terms of Use

Device Description: No description.

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?
44865	Vena cava filter, permanent	A permanently implanted vascular device intended to be percutaneously placed in the inferior vena cava (IVC) to prevent pulmonary embolism (PE). The device achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding, wire designs (e.g., conical, basket).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDW	Pin, Fixation, Threaded
HSB	Rod, Fixation, Intramedullary And Accessories

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: 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: 728c26bc-991c-4394-9f36-c10b7a27f102
Public Version Date: January 05, 2026
Public Version Number: 7
DI Record Publish Date: October 27, 2015