AccessGUDID - DEVICE: A. Titan Instruments (00841685104450)

GUDID

Device Identifier (DI) Information

Brand Name: A. Titan Instruments
Version or Model: PFI IPC GOLD 44
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: A. TITAN INSTRUMENTS, INC.

Primary DI Number: 00841685104450
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 037738874 *Terms of Use

Device Description: IPC GOLD COMPOSITE IN #44 handle

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:	No
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?
41861	Dental restoration carver, resin	A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIY	Instrument, Filling, Plastic, Dental

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 [?]
Dry Heat Sterilization

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: a2fb8aeb-175a-4b20-aecd-fe6cf0a0aed0
Public Version Date: January 24, 2023
Public Version Number: 1
DI Record Publish Date: January 16, 2023