AccessGUDID - DEVICE: First String Advanced Braided Retraction Cord Non-Impregnated

GUDID

Device Identifier (DI) Information

Brand Name: First String Advanced Braided Retraction Cord Non-Impregnated - Medium
Version or Model: 640109
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 640109
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: 00359883005641
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: Gingival retraction cord, non-medicated

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?
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 [?]
K981596	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
Handling Environment Temperature: less than 25 Degrees Celsius
Special Storage Condition, Specify: Keep away from heat, sparks and flame.

Clinically Relevant Size

[?]

Size Type Text
Length: 244 Centimeter

Device Record Status

Public Device Record Key: 7c8db86c-f2ea-44a8-abb2-a44d10d39d6d
Public Version Date: March 20, 2025
Public Version Number: 1
DI Record Publish Date: March 12, 2025