FDA.reportPublic FDA data

Retractor - Tongue and Cheek

Primary DI
00083208132223
Brand
Retractor - Tongue and Cheek
Company
Suncoast Dental, Inc
Model
Retractor T&C Set of 2
Catalog number
Retractor T&C Set of 2
Device description
Tongue and cheek retractor is used to hold cheeks, lips, and tongue away from the surgical area - Set of 2 - one large and one small retractor
Published
2021-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIGRetractor, All Types

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083208132223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208132223000832081322230832081322230083208132223

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
727-536-4880tatumcompliance@gmail.com

Regulatory Flags#

DUNS number
078352849
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

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