AccessGUDID - DEVICE: HSEU (10304040151447)

GUDID

Device Identifier (DI) Information

Brand Name: HSEU
Version or Model: 5702540
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5702540
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 10304040151447
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative andoperative dentistry used with gingival retraction cord. It is also intended to facilitate the insertion of the cord into the sulcus.

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?
46423	Gingival retraction solution	A liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., aluminium chloride). This device may also induce a local stasis of gingival exudates and gingival haemorrhages. After application, this device cannot be reused.	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
Special Storage Condition, Specify: Store between 2-30C
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d428b3fe-6d36-48ed-a6c2-158d9ff7c064
Public Version Date: December 06, 2021
Public Version Number: 2
DI Record Publish Date: March 12, 2021