AccessGUDID - DEVICE: BONDPRO™ ONE STEP ADHESIVE KIT 1-5gm SYRINGE (10190886000601)

GUDID

Device Identifier (DI) Information

Brand Name: BONDPRO™ ONE STEP ADHESIVE KIT 1-5gm SYRINGE
Version or Model: M960K-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: G & H Wire Company, Inc.

Primary DI Number: 10190886000601
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831465641 *Terms of Use

Device Description: One Step Adhesive intro kit. Contents: 1x5gm syringe, 3ml liquid etchant, 5ml primer, instructions.

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:	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?
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYH	Adhesive, Bracket And Tooth Conditioner, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981036	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b94bba05-a194-487b-bbcb-f8c4fd7db744
Public Version Date: January 31, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016