AccessGUDID - DEVICE: Sure-endo (08809264299654)

GUDID

Device Identifier (DI) Information

Brand Name: Sure-endo
Version or Model: SCP-000.0/S50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SURE DENT CORPORATION

Primary DI Number: 08809264299654
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688273010 *Terms of Use

Device Description: Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #000.0, 19.6 in (50cm)

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:	Yes
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?
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 [?]
K132526	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
Special Storage Condition, Specify: Store in a dry place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c53f098-2f2b-4ce5-9802-f3f210407e88
Public Version Date: February 25, 2025
Public Version Number: 2
DI Record Publish Date: August 27, 2024