AccessGUDID - DEVICE: Re-Cord™ Knitted Retraction Cord #2 (07540172009959)

GUDID

Device Identifier (DI) Information

Brand Name: Re-Cord™ Knitted Retraction Cord #2
Version or Model: 649105
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 649105
Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Primary DI Number: 07540172009959
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 626406016 *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):	No
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?
46037	Gingival retraction cord, medicated	A medicated (e.g., with epinephrine) 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: 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 Size Text, specify: Each bottle contains 244 cm of cord.

Device Record Status

Public Device Record Key: 5059b819-04e2-4ec1-ac08-d89a2648db80
Public Version Date: April 03, 2024
Public Version Number: 4
DI Record Publish Date: September 20, 2018