AccessGUDID - DEVICE: MTAFlow White 2.0 ml Gel (00850008515170)

GUDID

Device Identifier (DI) Information

Brand Name: MTAFlow White 2.0 ml Gel
Version or Model: 13866
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NUSMILE, LTD.

Primary DI Number: 00850008515170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 185497372 *Terms of Use

Device Description: Indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing root canals.

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?
36095	Endodontic filling/sealing material	A prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include (but are not limited to) silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). It does not include gutta-percha. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
Special Storage Condition, Specify: Keep bottles tightly closed
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Weight: 2.0 Gram

Device Record Status

Public Device Record Key: 78e8a887-86f4-4ec8-96bb-4d8fb0e08526
Public Version Date: July 28, 2020
Public Version Number: 1
DI Record Publish Date: July 20, 2020