AccessGUDID - DEVICE: ProShape One Gutta Percha Large (10810138822286)

GUDID

Device Identifier (DI) Information

Brand Name: ProShape One Gutta Percha Large
Version or Model: SDGP40061
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Endo Direct LLC

Primary DI Number: 10810138822286
Issuing Agency: GS1
Commercial Distribution End Date: November 14, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 125216703 *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?
45081	Synthetic gutta-percha	A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKM	Gutta-Percha

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: d2f8032c-6f0d-4c6e-b198-73de5e062b81
Public Version Date: November 15, 2024
Public Version Number: 2
DI Record Publish Date: July 15, 2023