AccessGUDID - DEVICE: Sonoma Orthopedic Products, Inc (00816988011705)

GUDID

Device Identifier (DI) Information

Brand Name: Sonoma Orthopedic Products, Inc
Version or Model: Sonoma Fibula Rod End Cap
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FIB6000
Company Name: ARTHREX, INC.

Primary DI Number: 00816988011705
Issuing Agency: GS1
Commercial Distribution End Date: July 07, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *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?
46139	Bone nail end-cap	A small, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. 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: 28300178-cfcd-48e5-b384-484aa49fbcd1
Public Version Date: April 07, 2021
Public Version Number: 5
DI Record Publish Date: August 19, 2015