AccessGUDID - DEVICE: EXPASYL strawberry flavor (03760243000713)

GUDID

Device Identifier (DI) Information

Brand Name: EXPASYL strawberry flavor
Version or Model: EXPASYL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 261001
Company Name: PRODUITS DENTAIRES PIERRE ROLLAN

Primary DI Number: 03760243000713
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 277657631 *Terms of Use

Device Description: Sulcular opening paste (x20 capsules).

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?
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: b3bae0ff-2646-4b2e-b836-ec6f4b6310ba
Public Version Date: March 11, 2025
Public Version Number: 2
DI Record Publish Date: September 20, 2022