FDA.reportPublic FDA data

Tubing set

Primary DI
ENOU1706A0
Brand
Tubing set
Company
Nouvag AG
Model
1706a
Device description
Tubing set for cooling
Published
2021-04-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042434000MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55NOUVAG AG2004-11-03DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENOU1706A9PrimaryHIBCC0
ENOU1706A0Unit of UseHIBCC0

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

Contacts#

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

Regulatory Flags#

DUNS number
480610476
Device count
10
DM exempt
false
Premarket exempt
false
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

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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

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Primary DI, Brand, Company table
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J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
07613327652703N/ASTRYKER CORPORATIONDZI2026-04-15
07613327652697N/ASTRYKER CORPORATIONDZI2026-04-13
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07613327652758N/ASTRYKER CORPORATIONDZI2026-03-25
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J021303870021SpeedControl SC1 (M-UK1023)W & H Dentalwerk Bürmoos GmbHDZI2023-10-12
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J021303920011Handpiece SA-40 L with cable 3.5 mW & H Dentalwerk Bürmoos GmbHDZI2022-10-19
J021303870001AMADEO M-UK1023W & H Dentalwerk Bürmoos GmbHDZI2022-08-23
J021300320031WS-75 LGW & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300530021S-9W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
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