FDA.report

SAFE DENT

Primary DI
00810339030438
Brand
SAFE DENT
Company
BGSS Company Inc.
Model
A90180P
Device description
A90180P PRE BENT TIP "liner" 18g" PINK BAG 100
Published
2024-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZMNeedle, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810339030438PackageGS125In Commercial Distribution
00810339030421PrimaryGS10
00810339030414Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810339030438008103390304388103390304380810339030438
00810339030421008103390304218103390304210810339030421
00810339030414008103390304148103390304140810339030414

GMDN Terms

TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
828474952
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810339030100SAFE DENTP50192024-05-15
00810339030322SAFE DENTM3010BL2024-05-15
00810339031138SAFE DENTM3011PK2024-05-15
00810339031398SAFE DENTH501392024-05-15
00810339031657SAFE DENTH501382024-05-15
00810339031831SAFE DENTLAB201M-BL2024-05-15
00810339031862SAFE DENTLAB202L-BL2024-05-15
00810339031893SAFE DENTLAB203XL-BL2024-05-15
00854014003034SAFE DENTSTP-7001-A2024-05-15
00854014003065SAFE DENTSTP-7002-B2024-05-15
00854014003096SAFE DENTSTP-7003-C2024-05-15
00854014003126SAFE DENTSTP-7004-D2024-05-15
00854014003157SAFE DENTSTP-7004-E2024-05-15
00854014003188SAFE DENTSTP-7006-F2024-05-15
00854014003645SAFE DENTPT8112W2024-05-15
00854014003683SAFE DENTPT8113BL2024-05-15
00854014003720SAFE DENTPT8114DR2024-05-15
00854014003751SAFE DENTPT8115LV2024-05-15
00854014003812SAFE DENTPT8117MG2024-05-15
00810339030018SAFE DENTP50132024-05-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810126508218Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCDZM2026-03-11
00810126508225Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCDZM2026-03-11
50192253037430MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037454MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037461MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037478MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037492MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037515MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037522MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037539MonojectCardinal Health 200, LLCDZM2026-02-10
00840456213629JMUJMU DENTAL, INCDZM2025-12-22
00840456213636JMUJMU DENTAL, INCDZM2025-12-22
00840456213643JMUJMU DENTAL, INCDZM2025-12-22
00840456213650JMUJMU DENTAL, INCDZM2025-12-22
00841336101029Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCDZM2025-11-11
00842517112360Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112384Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112421Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112476Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112483Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
08800123817903V-JectVERICOM CO., LTD.DZM2025-06-25
08800123817941V-JectVERICOM CO., LTD.DZM2025-06-25
08800123817965V-JectVERICOM CO., LTD.DZM2025-06-25
06936018502202baixinAnhui Kangda Medical Products Co.,Ltd.DZM2025-05-28
06936018502257baixinAnhui Kangda Medical Products Co.,Ltd.DZM2025-05-28
G001HSB1071100House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.DZM2024-09-06
86974456210057CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
86974456210217CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
86974456210224CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
G001HSB1071102House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.DZM2024-06-05