FDA.reportPublic FDA data

ProdiGI

Primary DI
10884521806863
Brand
ProdiGI
Company
Covidien LP
Model
ERD-TW20
Device description
Traction Wire
Published
2020-07-06
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
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
QSWEndoscopic Traction Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2
QSWEndoscopic Traction DeviceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220006000ProdiGICovidien, LLC2022-06-13QSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521806863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452180686310884521806863

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
Length20Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;
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
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
06959664944677NAHangzhou AGS MedTech Co., Ltd.PTS2026-08-21
00858836007126DiLumen Interventional GrasperLUMENDI LLCPTS2026-08-07
06934415028424ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029865ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029872ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029889ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029896ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029902ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029919ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029926ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029933ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029940ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029957ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029964ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029971ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029988ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029995ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030007ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030014ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030021ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030038ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030045ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030052ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030069ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030076ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030083ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030090ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030106ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030113ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030120ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18