AccessGUDID - DEVICE: ARTICULATING PAPER HORSESHOE, BLUE, THIN (07640159161721)

GUDID

Device Identifier (DI) Information

Brand Name: ARTICULATING PAPER HORSESHOE, BLUE, THIN
Version or Model: 36411
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Produits dentaires S.A.

Primary DI Number: 07640159161721
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480420090 *Terms of Use

Device Description: Articulating Papers are occlusal marking papers, whose aim is to highlight occlusion contacts, by creating a mark on the corresponding teeth surfaces (ink transfer). The products are used in the dentistry field. Pack of 6x12 sheets

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):	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?
16181	Dental articulation paper	A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFH	Paper, Articulation

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: 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: 117fe1c7-50e3-48ab-8baf-c510ed5f3bca
Public Version Date: July 06, 2022
Public Version Number: 1
DI Record Publish Date: June 28, 2022