FDA.reportPublic FDA data

Internal irrigation needle for Contra Angle 20:1 LED

Primary DI
ENOU391509
Brand
Internal irrigation needle for Contra Angle 20:1 LED
Company
Nouvag AG
Model
39150
Device description
Internal irrigation needle for Contra Angle 20:1 LED
Published
2018-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022505000CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,NOUVAG AG2003-10-01EGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENOU391509PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41718466600info@nouvag.com

Regulatory Flags#

DUNS number
480610476
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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ENOU33350MD 1133352017-01-13
ENOU3335SAL0MD 113335SAL2018-08-31
ENOU33600HighSurg 3033602017-01-13
ENOU42751150Vacuson 404275-1152017-01-13
ENOU42801150Vacuson 604280-1152017-01-13
ENOU5040NOU0Micro compass saw MSS 50005040NOU2018-08-21
ENOU5053NOU0Contra Angle 20:15053nou2017-04-27
ENOU5077NOU0CHP Handpiece5077NOU2018-08-21
ENOU5090NOU0Micro oscillating saw OMS 50005090NOU2018-08-21
ENOU5110NOU0Micro sagittal saw MOS 50005110NOU2018-08-21
ENOU5200NOU0Contra Angle 16:15200nou2017-04-27
ENOU5201NOU0Contra Angle 32:15201nou2017-04-27
ENOU33620LipoSurg33622018-08-21
ENOU42271150Vacuson 404227-1152018-08-21
ENOU4161US0Dispenser DP 30 LipoPlus4161US2017-01-13
ENOU4163US0Dispenser DP 30 LipoPlus4163US2017-01-13
ENOU4180US0Dispenser DP 304180US2017-01-13
ENOU4181US0Dispenser DP 30 LipoPlus4181US2017-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
00302730002911YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002928YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002935YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002942YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002959YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002997Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003000Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003017Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003024Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003031Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003055Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003062Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003079Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003086Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003093Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003109Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003116Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29