AccessGUDID - DEVICE: Monster Screw System (00889795001238)

GUDID

Device Identifier (DI) Information

Brand Name: Monster Screw System
Version or Model: P20-070-WF00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P20-070-WF00
Company Name: Paragon 28, Inc.

Primary DI Number: 00889795001238
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042961576 *Terms of Use

Device Description: Flat Washer for Monster Screw 7.0mm

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?
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTN	WASHER, BOLT NUT

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
Device Size Text, specify: Flat Washer for Monster Screw 7.0mm
Outer Diameter: 2 Millimeter

Device Record Status

Public Device Record Key: 68bb14af-fb75-4e7f-a0e9-26b70e80c6a9
Public Version Date: April 22, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016