AccessGUDID - DEVICE: isolate (D052I5NLMB1)

GUDID

Device Identifier (DI) Information

Brand Name: isolate
Version or Model: i5NLMB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: i5NLMB
Company Name: Endo/Tech

Primary DI Number: D052I5NLMB1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 253314280 *Terms of Use

Device Description: isolate Non Latex Dental Dam in Medium Blue. Each sheet measures 5x5 and is manufactured from Polyisoprene.

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):	No
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3eecfc53-b5d3-4c33-af2a-188919ec5ea3
Public Version Date: February 20, 2024
Public Version Number: 1
DI Record Publish Date: February 12, 2024