AccessGUDID - DEVICE: Dentsply Sirona (D0026263821)

GUDID

Device Identifier (DI) Information

Brand Name: Dentsply Sirona
Version or Model: 626382
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 626382
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026263821
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Dentsply Sirona Intraoral Tip Refill (Clear)

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":	Yes
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?
60366	Dental material injection cannula, single-use	A rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

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 24 Degrees Celsius
Special Storage Condition, Specify: Protect from moisture.
Special Storage Condition, Specify: Keep out of direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 100 Intraoral Tips (Clear)

Device Record Status

Public Device Record Key: 5f4b1478-7094-4d97-b74d-7dccf677a17f
Public Version Date: September 02, 2022
Public Version Number: 2
DI Record Publish Date: August 24, 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: D0026263820 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)532-2855
Email: MilfordDE-Customer-Service@dentsplysirona.com

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