FDA.reportPublic FDA data

Tubing set

Primary DI
ENOU17089
Brand
Tubing set
Company
Nouvag AG
Model
1708
Device description
Tubing set for cooling
Published
2018-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
ENOU17089PrimaryHIBCC0
ENOU17080Unit 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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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ENOU33620LipoSurg33622018-08-21
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ENOU4163US0Dispenser DP 30 LipoPlus4163US2017-01-13
ENOU4180US0Dispenser DP 304180US2017-01-13
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