AccessGUDID - DEVICE: EdgeDam™ Refill Heavy 6x6 Latex (00359883006693)

GUDID

Device Identifier (DI) Information

Brand Name: EdgeDam™ Refill Heavy 6x6 Latex
Version or Model: 838237-E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EDBLH6636
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: 00359883006693
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: Low Protein Latex 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):	Yes
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?
11155	Rubber dam, Hevea-latex	A sheet of elastomeric material made of Hevea natural rubber latex (NRL) 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 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
Storage Environment Temperature: less than 25 Degrees Celsius
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 36 Square inch

Device Record Status

Public Device Record Key: 9d53545a-870f-441b-a935-3737e71c2edd
Public Version Date: March 20, 2025
Public Version Number: 1
DI Record Publish Date: March 12, 2025