AccessGUDID - DEVICE: Keystone Industries (H66819007201)

GUDID

Device Identifier (DI) Information

Brand Name: Keystone Industries
Version or Model: 1900720
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1900720
Company Name: Keystone Industries

Primary DI Number: H66819007201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 073503117 *Terms of Use

Device Description: Pkg/5x1 Ft Clasp Wire 12Ga H/R

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?
42879	Denture clasp, metal, custom-made	A dental device made of metal, typically in wire form, intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet the specifications of an individual patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJW	CLASP, WIRE

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
Width: 2 Millimeter

Device Record Status

Public Device Record Key: ca57f556-f572-457e-bf34-d47f1fe16be6
Public Version Date: December 08, 2022
Public Version Number: 1
DI Record Publish Date: November 30, 2022