AccessGUDID - DEVICE: ACTEON (03760243001048)

GUDID

Device Identifier (DI) Information

Brand Name: ACTEON
Version or Model: EXPASYL EXACT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRODUITS DENTAIRES PIERRE ROLLAN

Primary DI Number: 03760243001048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 277657631 *Terms of Use

Device Description: Expasyl is a paste for temporary gingival retraction that ensures separation of the marginal gingiva and drying of 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:	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?
16352	Gingival retraction kit	A collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. 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 [?]
K050180	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
Storage Environment Temperature: between 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8f8f0617-8b14-4554-9b74-36d055756dce
Public Version Date: March 11, 2025
Public Version Number: 2
DI Record Publish Date: March 04, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
03760243007170	20	03760243001048	In Commercial Distribution
03760243007187	50	03760243001048	In Commercial Distribution
03760243007194	5	03760243001048	In Commercial Distribution