AccessGUDID - DEVICE: Paul Banditt (D955CROSY1)

GUDID

Device Identifier (DI) Information

Brand Name: Paul Banditt
Version or Model: CROSY
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Terlain Enterprises, Inc.

Primary DI Number: D955CROSY1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177465051 *Terms of Use

Device Description: PAUL BANDITT SY PLIERS, With Set Screw, For crown removal, w/ 2 sets silicone inserts

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?
64480	Dental implant/prosthesis handling forceps	A hand-held manual dental instrument designed for grasping and holding a dental implant and/or prosthesis (e.g., crown, bridge, screw) during its application to a patient's oral cavity. It typically has a tweezers-like design consisting of two conjoined blades with serrated tips at the working end; some types have graduated markings on the tips for gauging. It is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in various sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIS	Remover, Crown

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 [?]
Moist Heat or Steam 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: eb7bf1ea-8de7-47b0-aa28-aff720a131f8
Public Version Date: December 19, 2023
Public Version Number: 1
DI Record Publish Date: December 11, 2023