AccessGUDID - DEVICE: GT Series X Obturator (D716SXOB300461)

GUDID

Device Identifier (DI) Information

Brand Name: GT Series X Obturator
Version or Model: SXOB30046
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SXOB30046
Company Name: TULSA DENTAL PRODUCTS LLC

Primary DI Number: D716SXOB300461
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 942778564 *Terms of Use

Device Description: Obturator: SX PL 30/.04 6pk

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?
47751	Warm-bonded endodontic obturation system obturator	A hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. This is a single-use device.	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: Yes

Sterilization Method [?]
Liquid Chemical

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: 8e79d70e-4f5f-4841-a859-0ce8e7d09bb9
Public Version Date: August 08, 2022
Public Version Number: 1
DI Record Publish Date: July 29, 2022