AccessGUDID - DEVICE: Amtouch Etchant Gel (00850048528994)

GUDID

Device Identifier (DI) Information

Brand Name: Amtouch Etchant Gel
Version or Model: 1.2ml (24 pack)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AMETCH24
Company Name: AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.

Primary DI Number: 00850048528994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 180611519 *Terms of Use

Device Description: Amtouch Etchant Gel 37%, Medium Viscosity, 1.2ml (24x Syringes)

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?
36153	Dental etching solution	An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. 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 [?]
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
Special Storage Condition, Specify: Special Storage

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d558cf7a-dd72-47c4-abcd-7cf6dc1fa169
Public Version Date: May 23, 2024
Public Version Number: 1
DI Record Publish Date: May 15, 2024