AccessGUDID - DEVICE: NEW METAL STRIPS (14548161391610)

GUDID

Device Identifier (DI) Information

Brand Name: NEW METAL STRIPS
Version or Model: 000251
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000251
Company Name: Gc America Inc.

Primary DI Number: 14548161391610
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: NEW METAL STRIPS Assortment "A" Package, #200 Mesh Extra Coarse (four A, four B and four C widths) Red

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?
35702	Dental abrasive strip, single-use	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHM	STRIP, POLISHING AGENT

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: 8387310d-0add-4d4c-9260-3cbd83c46627
Public Version Date: August 15, 2022
Public Version Number: 1
DI Record Publish Date: August 05, 2022