BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Paro® Non-Latex Rubber Dam

DI: 07540172014571 · Model: 838080 · CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Paro® Non-Latex Rubber Dam
Primary DI: 07540172014571
Version / Model: 838080
Catalog Number: 838080
Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Labeler DUNS: 626406016
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2020-03-17
Public Version: 2
Public Version Date: 2022-11-03
Public Version Status: Update
Public Device Record Key: 82a81a8e-3ce5-480f-86f2-771ca497d55b
Distribution End Date: 2021-05-26

Device Description

Dental isolation dam

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: Yes
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIE	DAM, RUBBER	Dental	872.6300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540172014571	GS1

Customer Contacts

Phone: +1(800)265-3444
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	36	Square inch
Device Size Text, specify			20 x 36 [sin_i] Dam