AccessGUDID - DEVICE: Rally™ (00810038095196)

GUDID

Device Identifier (DI) Information

Brand Name: Rally™
Version or Model: FPCK02-X
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FPCK02-X
Company Name: GARRISON DENTAL SOLUTIONS, L.L.C.

Primary DI Number: 00810038095196
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057647005 *Terms of Use

Device Description: Composite Polisher Cup Assortment Pack: 24 Polishers (10) Coarse Cups, (10) Medium Cups, (4) Fine Cups

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):	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?
62764	Dental matrix band kit	A collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHJ	Disk, Abrasive

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: 09471dc0-5807-4744-b99d-6cc2505ea327
Public Version Date: May 04, 2020
Public Version Number: 1
DI Record Publish Date: April 24, 2020