AccessGUDID - DEVICE: OVC3 One Visit Crown (09421031795573)

GUDID

Device Identifier (DI) Information

Brand Name: OVC3 One Visit Crown
Version or Model: OVC3 McDonald Matrix Band - Premolar Accessories Pack
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9421031795573
Company Name: RHONDIUM LIMITED

Primary DI Number: 09421031795573
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595078345 *Terms of Use

Device Description: Packages contain x6 matrix bands for upper premolars 14.15 S (small), 14.15 M (medium), 14.15 L (large), 24.25 S (small), 24.25 M (medium), 24.25 L (large), x6 matrix bands for lower premolars 34.35 S (small), 34.35 M (medium), 34.35 L (large), 44.45 S (small), 44.45 M (medium), 44.45 L (large), x 16 stretch wedges

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:	Yes
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?
38786	Dental matrix band, single-use	A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 5c44fb83-7914-41d8-9b33-ad515982e4cc
Public Version Date: March 14, 2019
Public Version Number: 2
DI Record Publish Date: November 28, 2018