FDA.reportPublic FDA data

NA

Primary DI
ETDG186778
Brand
NA
Company
medmix Deutschland GmbH
Model
16G 1.6 x 39 mm, Luer Lock, blunt, in blister, hub
Catalog number
186778
Device description
Sterile Suction Needles are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site during oral surgery. The device is a semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, irrigating solutions and water during a dental or oral procedure. Suction Needles are to be locked on a Luer Lock connection. It is not intended to penetrate tissue (it is not an injection needle). The cannula is made of stainless steel. This is a single-use device.
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ETDG1867782PrimaryHIBCC0
ETDG186778Unit of UseHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314320603
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ETDG1867772NA14G 2.1 x 39 mm, Luer Lock, blunt, in blister, hub1867772024-10-01
ETDG1867782NA16G 1.6 x 39 mm, Luer Lock, blunt, in blister, hub1867782024-10-01
ETDG1867792NA18G 1.2 x 39 mm, Luer Lock, blunt, in blister, hub1867792024-10-01
ETDG1867802NA20G 0.9 x 39 mm, Luer Lock, blunt, in blister, hub1867802024-10-01
ETDG186777NA14G 2.1 x 39 mm, Luer Lock, blunt, in blister, hub1867772024-10-01
ETDG186779NA18G 1.2 x 39 mm, Luer Lock, blunt, in blister, hub1867792024-10-01
ETDG186780NA20G 0.9 x 39 mm, Luer Lock, blunt, in blister, hub1867802024-10-01
ETDG1620622NA14G 2.1 x 39 mm, Luer Lock, blunt, in blister, hub1620622023-01-25
ETDG1620632NA16G 1.6 x 39 mm, Luer Lock, blunt, in blister, hub1620632023-01-25
ETDG1620642NA18G 1.2 x 39 mm, Luer Lock, blunt, in blister, hub1620642023-01-25
ETDG1620652NA20G 0.9 x 39 mm, Luer Lock, blunt, in blister, hub1620652023-01-25
ETDG1620542NA27G 0.4 x 32 mm, Luer Lock, single apical side ven1620542024-09-15
ETDG1620552NA30G 0.3 x 32 mm, Luer Lock, single apical side ven1620652024-09-15
ETDG162054NA27G 0.4 x 32 mm, Luer Lock, single apical side ven1620542024-09-15
ETDG162065NA30G 0.3 x 32 mm, Luer Lock, single apical side ven1620652024-09-15
ETDG1620662NA23G 0.6 x 25 mm, Luer Lock, double side vent, clos1620662023-01-26
ETDG1620672NA25G 0.5 x 25 mm, Luer Lock, double side vent, clos1620672023-01-26
ETDG1620682NA27G 0.4 x 25 mm, Luer Lock, double side vent, clos1620682023-01-26
ETDG1620692NA30G 0.3 x 25 mm, Luer Lock, double side vent, clos1620692023-01-26
ETDG1665842NA30G 0.3 x 25 mm, short, RW (regular wall), hub dar1665842023-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454001493COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454002162COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454002179COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454004807COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454004852COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454012802COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454012826COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454000878COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-02
06954454002155COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-02
06954454002148COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-31
06954454002445COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-31
06954454003237COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-31
06954454004975COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-31
06954454000069COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000076COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000083COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000090COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000106COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000113COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001509COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001684COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001691COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001707COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001714COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001721COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001738COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001745COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015315COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015322COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015339COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28