FDA.reportPublic FDA data

Lip Retractor

Primary DI
07333117000179
Brand
Lip Retractor
Company
Gestenco International AB
Model
LR-00-02
Catalog number
LR-00-02
Published
2020-10-15
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
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333117000179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333117000179073331170001797333117000179

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

Regulatory Flags#

DUNS number
354936098
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333117000193Mark VI IPR Gauge setMK-00-012026-04-30
07333117010000Rodney Aligner Seaters, mintRAS-0012026-04-30
07333117010017Rodney Aligner Seaters, lemonRAS-0022026-04-30
07333117010024Rodney Aligner Seaters, melonRAS-0032026-04-30
07333117010369Rodney Aligner SeatersRAS-0042026-04-30
07333117000032SmartBondSM-002SM-0022020-10-15
07333117000049SmartBondSM-001SM-0012020-10-15
07333117000056SmartBond LCSM-100-LCSM-100-LC2020-10-15
07333117000063SmartBond LCSM-300-LCSM-300-LC2020-10-15
07333117000087FreddyFCB-00-01FCB-00-012020-10-14
07333117000223FreddyFCB-00-01HKFCB-00-01HK2020-10-14
07333117000018SmartBondSM-000SM-0002016-10-11
07333117000025SmartBondSM-010SM-0102016-10-11
07333117000216SpringtimeKITSP-55-55HKSKITSP-55-55HKS2017-01-13
07333117000070Bite-BumperBB-00-01BB-00-012016-10-11
07333117000148Cheek retractorCR-00-01CR-00-012020-10-15
07333117000162Lip RetractorLR-00-01LR-00-012020-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000250COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000885COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000892COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000908COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000915COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000922COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000939COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000946COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000953COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000960COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002001COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002308COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002315COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002803COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002810COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002827COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002834COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002841COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454004876COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454005019COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454005026COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006085COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006214COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006221COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006245COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006252COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006429COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454011867COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013489COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013496COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21