AccessGUDID - DEVICE: Small Endo Ultra Tip Kit (10818207022131)

GUDID

Device Identifier (DI) Information

Brand Name: Small Endo Ultra Tip Kit
Version or Model: 407706
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vista Dental

Primary DI Number: 10818207022131
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036623932 *Terms of Use

Device Description: No description.

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:	No
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?
61428	Endodontic lavage system	An assembly of devices intended to enable lavage, through simultaneous irrigation and aspiration, of a prepared root canal to remove debris/bacteria. It is intended to be connected to the central vacuum line and includes appropriate vacuum line/syringe adaptor(s), tubing, and one or more suction cannulae (typically disposable). The suction cannulae are intended to draw irrigation solution to the apex of the root canal to flush the entire canal.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JET	Pick, Massaging

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: c2e92742-5a71-4c42-a72b-ed420ff1f3f3
Public Version Date: September 09, 2022
Public Version Number: 1
DI Record Publish Date: September 01, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 2626369755
Email: info@vista-dental.com

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