FDA.reportPublic FDA data

ProdiGI

Primary DI
20884521808390
Brand
ProdiGI
Company
Covidien LP
Model
ERD-TMST
Device description
Traction Magnet
Published
2022-07-15
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
QSWEndoscopic Traction Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSWEndoscopic Traction DeviceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521808390PackageGS12In Commercial Distribution
10884521808393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452180839020884521808390
1088452180839310884521808393

GMDN Terms#

Term, Definition table
TermDefinition
Internally-anchored endoscopic retractorA sterile, nonimplantable, intraoperative surgical instrument designed to be inserted into the abdominal or thoracic cavity through a compatible endoscopic instrument (e.g., an access port) to provide hands-free retraction of a selected organ by anchoring it to the cavity wall during a surgical intervention (e.g., gastroenterological, gynaecological and urological laparoscopic or thoracoscopic procedures). It is inserted using a dedicated applier and typically consists of two interconnected clips that clutch the tissue for anchoring to the cavity wall and grasping the organ. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius22 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503563017SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563024SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563031SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563048SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563055SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563062SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563079SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563086SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563093SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563109SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563116SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563123SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563130SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563147SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563014MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563021MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563038MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563045MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563052MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563069MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563076MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563083MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563090MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563106MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563113MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563120MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563137MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563144MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
10884521808393ProdiGICovidien LPQSW2022-07-15
10884521808409ProdiGICovidien LPQSW2022-07-15