FDA.reportPublic FDA data

EFFITEC NEEDLE 27G SHORT

Primary DI
03760349800514
Brand
EFFITEC NEEDLE 27G SHORT
Company
DENTALHITEC
Model
C3029
Catalog number
C3029
Device description
1 box of 100 single use needles 27G 16mm
Published
2023-08-22
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
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760349800514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760349800514037603498005143760349800514

GMDN Terms#

Term, Definition table
TermDefinition
Dental syringe needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
640616736
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760349801054QUICKSLEEPER 5C_A2 US/CAQS_5C_A2QS_5C_A22025-12-22
03760349803331SleeperOne 5SO_5CSO-5C2023-08-22
03760349805335SoanSOAN1SOAN12023-08-22
03760349800507EFFITEC NEEDLE 30G EXTRA SHORTC3022C30222023-08-22
03760349800521EFFITEC NEEDLE 30G SHORTC3025C30252023-08-22
03760349809913SleeperOne 5SO_5CSO-5C2023-08-22
03760349809951SoanSOAN1SOAN12023-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D832BLT100501PlasdentPLASDENT CORPORATIONDZM2026-05-28
D1250802Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250812Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250822Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10012Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10022Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10072Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10122Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D832BLT1011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT2001PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT2011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3001PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3021PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4181PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4201PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4211PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4221PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4231PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4251PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4271PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5221PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT522B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5231PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT523B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5251PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT525B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT6301PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT630M1PlasdentPLASDENT CORPORATIONDZM2026-05-01
20192253037422MonojectCardinal Health 200, LLCDZM2026-04-02