FDA.reportPublic FDA data

Emotec srl

Primary DI
08053369431048
Brand
Emotec srl
Company
EMOTEC SRL
Model
1
Catalog number
8000001
Device description
Sterile kit for peristaltic pump us
Published
2021-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDKProsthesis, Hip, Cement Restrictor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDKProsthesis, Hip, Cement RestrictorGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08053369431048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053369431048080533694310488053369431048

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
+003953553060quality@emotec.it

Regulatory Flags#

DUNS number
655114713
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497002842MectaCem BonePrepTECRES SPAJDK2022-11-17
07630345710963MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710970MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710987MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710994MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345711007MectaPlug PE IIMedacta International SAJDK2021-04-16
00840019908757ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908764ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908771ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908788ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908795ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908801ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908818ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908825ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908832ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908849ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908856ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908863ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908870ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908887ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908894ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908900ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00815362022122ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929233ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929257ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929240ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
00840019929264ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
00840019929271ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
08031497001401Cement RestrictorTECRES SPAJDK2015-10-12
08031497001418Cement RestrictorTECRES SPAJDK2015-10-12