FDA.reportPublic FDA data

ProdiGI

Primary DI
10884521808409
Brand
ProdiGI
Company
Covidien LP
Model
ERD-TMLG
Device description
Traction Magnet
Published
2022-07-15
Public version status
Update
Distribution status
Not 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
QSWEndoscopic Traction Device

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521808406PackageGS12Not in Commercial Distribution
10884521808409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452180840620884521808406
1088452180840910884521808409

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
Length17Millimeter

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521032903BiosynGMT-2262015-09-01
10884521102163Vascufil88864788-05V2015-08-31
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29

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
20884521808390ProdiGICovidien LPQSW2022-07-15