AccessGUDID - DEVICE: SilTrax AS Retraction Cord 10/2 (00310866000350)

GUDID

Device Identifier (DI) Information

Brand Name: SilTrax AS Retraction Cord 10/2
Version or Model: 07120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07120
Company Name: PASCAL COMPANY, INC.

Primary DI Number: 00310866000350
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009260217 *Terms of Use

Device Description: Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 10/2

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:	Yes
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?
35861	Gingival retraction cord, non-medicated	A non-medicated cotton string intended to be used to temporarily push gum tissue (gingiva) away from prepared tooth margins to help make an accurate dental impression. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVL	Cord, Retraction

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
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 25b21fe8-844f-4cad-bf8c-9b2f5816db85
Public Version Date: April 03, 2024
Public Version Number: 3
DI Record Publish Date: January 24, 2019