AccessGUDID - DEVICE: Markley Threaded Wire .060 (D248380600)

GUDID

Device Identifier (DI) Information

Brand Name: Markley Threaded Wire .060
Version or Model: 38060
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HAGER WORLDWIDE, INC.

Primary DI Number: D248380600
Issuing Agency: HIBCC
Commercial Distribution End Date: August 01, 2023
Device Count: 2
Labeler D-U-N-S® Number*: 009277971 *Terms of Use

Device Description: Stainless Steel Threaded Wire (Used for Pins and Posts)

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):	No
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?
38609	Root canal post, preformed	A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBL	PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: 7e170593-4efc-4516-9107-ed59a28c0023
Public Version Date: September 18, 2023
Public Version Number: 3
DI Record Publish Date: April 10, 2023