AccessGUDID - DEVICE: AOS HUMERAL NAIL 9mm x 22.5cm (00848665005691)

GUDID

Device Identifier (DI) Information

Brand Name: AOS HUMERAL NAIL 9mm x 22.5cm
Version or Model: S1173-225
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Primary DI Number: 00848665005691
Issuing Agency: GS1
Commercial Distribution End Date: June 14, 2017
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?
38153	Humerus intramedullary nail	A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the humerus to immobilize the ends of a fractured bone in position to promote healing; it may also be used to support the bone in the presence of a pathological condition. It may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
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: Yes
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
No Device Sizes

Device Record Status

Public Device Record Key: 385235e6-0011-4637-91f7-c956856b231f
Public Version Date: February 06, 2025
Public Version Number: 5
DI Record Publish Date: October 09, 2015