AccessGUDID - DEVICE: Maarc dental - Articulating Paper (08906110440175)

GUDID

Device Identifier (DI) Information

Brand Name: Maarc dental - Articulating Paper
Version or Model: 5521/001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5521/001
Company Name: SHIVA PRODUCTS

Primary DI Number: 08906110440175
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2050
Device Count: 1
Labeler D-U-N-S® Number*: 737988276 *Terms of Use

Device Description: A diagnostic tool used in dentistry to highlight occlusal contacts and the distribution of occlusal forces. That is, it marks those points on the teeth where the teeth contact during biting and grinding.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cbddc56b-42fa-4737-b87a-23142d25bce7
Public Version Date: October 10, 2024
Public Version Number: 1
DI Record Publish Date: October 02, 2024