AccessGUDID - DEVICE: Articulating Film (10732224001835)

GUDID

Device Identifier (DI) Information

Brand Name: Articulating Film
Version or Model: TFMBKR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CROSSTEX INTERNATIONAL, INC.

Primary DI Number: 10732224001835
Issuing Agency: GS1
Commercial Distribution End Date: August 24, 2023
Device Count: 25
Labeler D-U-N-S® Number*: 057728685 *Terms of Use

Device Description: Articulating Fim, Black-Red Combo,13 µ

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:	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: a44e622a-ca9b-442e-b32a-277909275635
Public Version Date: August 25, 2023
Public Version Number: 2
DI Record Publish Date: September 29, 2022