AccessGUDID - DEVICE: EdgeDam™ Refill Medium 5x5 Latex-Free (00359883006723)

GUDID

Device Identifier (DI) Information

Brand Name: EdgeDam™ Refill Medium 5x5 Latex-Free
Version or Model: 838200-E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EDVLFM5550
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: 00359883006723
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: Premium Polyisoprene Dental Dam

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?
45004	Rubber dam, non-latex	A sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIE	DAM, RUBBER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 at room temperature
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 25 Square inch

Device Record Status

Public Device Record Key: 44077456-6f7e-4d62-a5ae-d9bc62b4b632
Public Version Date: March 20, 2025
Public Version Number: 1
DI Record Publish Date: March 12, 2025