FDA.reportPublic FDA data

NA

Primary DI
ETDG1867782
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
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

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA 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, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Regulatory Flags#

DUNS number
314320603
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
ETDG186778NA16G 1.6 x 39 mm, Luer Lock, blunt, in blister, hub1867782024-10-01
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
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