AccessGUDID - DEVICE: Accessory (10810111542712)

GUDID

Device Identifier (DI) Information

Brand Name: Accessory
Version or Model: X-80580P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X-80580P
Company Name: BISCO INC.

Primary DI Number: 10810111542712
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053529939 *Terms of Use
Previous DI: D757X80580P1

Device Description: Select HV Etch Empty Syringe Accessory Pack - 30 Empty Disposable Syringes, 30 Disposable Syringe Tips

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):	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?
63696	Dental etching solution syringe	A hand-held, manual dental instrument consisting of a barrel (cylinder) with plunger intended to be used to dispense dental etching solution (etchant) to a patient’s tooth/teeth. It is intended to be filled once and used on multiple patients; disposable dispensing tips may be included. This device is reusable until the contents of the syringe are exhausted.	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 22702834-87d0-4ac9-a60b-e1303dd56f2c
Public Version Date: January 25, 2023
Public Version Number: 1
DI Record Publish Date: January 17, 2023